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.     

Blood donation in Chile: Replacement and volunteer donors

In recent years, the Chilean Health Ministry has developed a strategy in order to improve the safety and opportunity of the blood supply through the creation of a nationally co-ordinated blood transfusion service, centralizing collection management, production and testing in three Blood Centers along the country and promoting voluntary, regular, blood donation.In 2007, a comprehensive study of the situation of Blood Transfusion Services in Chile concluded that several critical factors make it difficult to achieve a safe and adequate access to blood and blood components in the country. For example there is a low donation rate (14.3/1000 inhabitants), very low percentage of voluntary donors (10%), excessive amount of blood banks collecting, processing and testing blood revealing an atomized non-centralized system, lack of a national IT system and insufficient national standards. There are two regions in the country, Bio Bio and Valparaíso, where Regional Blood Centers are located, that have put in place several strategies in order to obtain better results.     

Supply of human allograft tissue in Canada

There is relatively little known about the supply for allograft tissues in Canada. The major aim of this study is to quantify the current or “Known Supply” of human allograft tissue (bone, tendons, soft tissue, cardiovascular, ocular and skin) from known tissue banks in Canada, to estimate the “Unknown Supply” of human allograft tissue available to Canadian users from other sources, and to investigate the nature and source of these tissue products. Two surveys were developed; one for tissue banks processing one or more tissue types and the other specific to eye banks. Thirty nine sites were initially identified as potential tissue bank respondent sites. Of the 39 sites, 29 sites indicated that they were interested in participating or would consider completing the survey. A survey package and a self-addressed courier envelope were couriered to each of 29 sites. A three week response time was indicated. The project consultants conducted telephone and email follow-up for incomplete data. Unknown supply was estimated by 5 methods. Twenty-eight of 29 sites (97%) completed and returned surveys. Over the past year, respondents reported a total of 5,691 donors (1,550 living and 4,141 cadaveric donors). Including cancellous ground bone, there were 10,729 tissue products produced by the respondent banks. Of these, 71% were produced by accredited banks and 32% were ocular tissues. Total predicted shortfall of allograft tissues was 31,860–66,481 grafts. Through estimating Current supply, and compiling additional qualitative information, this study has provided a snapshot of the current Canadian supply and shortfall of allograft tissue grafts.     

Demand for human allograft tissue in Canada

There is relatively little known about the demand for allograft tissues in Canada. The Canadian Council for Donation and Transplantation (CCDT) is a national advisory body that undertook a comprehensive “market survey” to estimate surgical demand for human allograft tissues in Canada. The report “Demand for Human Allograft Tissue in Canada” reflects survey results sent to 5 prominent User Groups. User Groups were identified as orthopaedic surgeons; neurosurgeons; corneal transplant surgeons; plastic surgeons, specifically those at Canadian Burn Units; and cardiac surgeons (adult and paediatric surgery). The demand for allograft grafts was determined and then extrapolated across the total User Group and then increases in allograft tissue use over the next 1–2 years across User Groups were predicted. The overall response rate for the survey was 21.4%. It varied from a low of 19.6% for the orthopaedic survey to a high of 40.5% for the corneal survey. The estimated current demand for allograft tissue in Canada ranges from a low of 34,442 grafts per year to a high of 62,098 grafts per year. The predicted increase in use of allograft tissue over the next 1–2 year period would suggest that annual demand could rise to somewhere in the range of 42,589–72,210 grafts. The highest rated preferences (98% and 94%) were for accredited and Canadian tissue banks, respectively. This study represents a key step in addressing the paucity of information concerning the demand for allograft tissue in Canada.     

Evaluation of the experiences of family members whose deceased relative donated tissues at the NHSBT dedicated donation facility in Speke, Liverpool

Donation of human tissue for transplant and research has historically been facilitated within the hospital mortuary. In 2006 NHSBT Tissue Services opened the Dedicated Donation Facility [DDF], the first facility in the UK dedicated to the donation of tissues under strictly controlled conditions. Nine family members who had agreed and experienced the transfer of their deceased relative to the DDF for tissue donation participated in a service evaluation applying qualitative data collection methods and framework analysis. The evaluation aimed to: understand the decision-making process of family members who agreed to their deceased relative being moved to the DDR for tissue donation; identify any concerns that family members had; gather the views of family members regarding the 'service' provided to them by NHSBT Tissue Services. Family members were unaware of the possibility of tissue donation. The process of reasoning behind both agreeing to tissue donation and movement of the deceased to the DDF by family members was fundamentally, 'the benefit to others' that tissue donation would bring, and fulfilling the wishes of the deceased [when known]. Family decision making was facilitated by: (i) a positive rapport with the requester, (ii) satisfaction with the information provided to the family about what would happen, and (iii) trust in that what was being said would happen. Family members were satisfied with the service provided to them by Tissue Services and confident in agreeing to the transfer of their deceased relative to the dedicated facility for tissue donation.     

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.     

Guidelines for the investigation of individuals who were place under surveillance for tuberculosis post-landing in Canada. Canadian Thoracic Society,the Tuberculosis Directors of Canada and the Department of National Health and Welfare.

There are 2 parts to this article. Part 1 is a preamble, jointly prepared by Immigration and Overseas Health Services, Medical Services Branch and the Bureau of Communicable Disease Epidemiology, LCDC, Department of National Health and Welfare, to provide background information regarding the medical assessment of immigrants prior to landing in Canada. Part 2 is a set of guidelines for the investigation of individuals who were placed under surveillance for tuberculosis post-landing in Canada. It was jointly prepared by the Canadian Thoracic Society, the Tuberculosis Directors of Canada and the Department of National Health and Welfare in consultation with the provincial and territorial epidemiologists and has been approved by the Canadian Lung Association and the Canadian Thoracic Society.     

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.     

European coding system for tissues and cells: a challenge unmet?

The Comité Européen de Normalisation (European Committee for Standardization, CEN) Workshop on Coding of Information and Traceability of Human Tissues and Cells was established by the Expert Working Group of the Directorate General for Health and Consumer Affairs of the European Commission (DG SANCO) to identify requirements concerning the coding of information and the traceability of human tissues and cells, and propose guidelines and recommendations to permit the implementation of the European Coding system required by the European Tissues and Cells Directive 2004/23/EC (ED). The Workshop included over 70 voluntary participants from tissue, blood and eye banks, national ministries for healthcare, transplant organisations, universities and coding organisations; mainly from Europe with a small number of representatives from professionals in Canada, Australia, USA and Japan. The Workshop commenced in April 2007 and held its final meeting in February 2008. The draft Workshop Agreement went through a public comment phase from 15 December 2007 until 15 January 2008 and the endorsement period ran from 9 April 2008 until 2 May 2008. The endorsed CEN Workshop Agreement (CWA) set out the issues regarding a common coding system, qualitatively assessed what the industry felt was required of a coding system, reviewed coding systems that were put forward as potential European coding systems and established a basic specification for a proposed European coding system for human tissues and cells, based on ISBT 128, and which is compatible with existing systems of donation identification, traceability and nomenclatures, indicating how implementation of that system could be approached. The CWA, and the associated Workshop proposals with recommendations, were finally submitted to the European Commission and to the Committee of Member States that assists its management process under article 29 of the Directive 2004/23/EC on May 25 2008. In 2009 the European Commission initiated an impact assessment on the Workshop proposals and recommendations. In the absence of an agreed pan-European direction various initiatives have continued work using, adopting or adapting their preferred, or existing, methods.     

The importance of ethic in the field of human tissue banking

A tissue bank is accountable before the community in fulfilling the expectations of tissue donors, their families and recipients. The expected output from the altruistic donation is that safe and high quality human tissue grafts will be provided for the medical treatment of patients. Thus, undertakings of tissue banks have to be not only authorised and audited by national competent health care authorities, but also comply with a strong ethical code, a code of practices and ethical principles. Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of human tissues for transplantation. The opinions and suggestions manifested by the authors in this paper may not be necessarily a reflection of those within the institutions or community they are linked to.     

"I won't do surgery if you don't try to do my job," head of new blood agency tells MDs

Ken Fyke is known as a tough administrator, and he is going to need all of his administrative tricks as first chair of Canadian Blood Services, the new national organization that is taking over responsibility for the nation''s blood supply from the Red Cross come September. Fyke says he hopes to work closely with physicians, but they will have to realize where their responsibilities end and his begin.     

Registry of unrelated bone marrow donors.

Reports of successful transplantation of bone marrow obtained from unrelated donors who were histocompatibility leukocyte antigen (HLA) identical prompted the Canadian Red Cross Blood Transfusion Service in Ottawa to assess the possibility of developing a bone marrow donor registry in Canada. We sent a pamphlet that explained the program to 1568 people who had undergone apheresis and asked them to reply, stating their interest. At the same time the pamphlets and a poster were placed in the blood donor clinic. We received 1232 replies (78.6%) from the apheresis donors, 838 (68.0%) of which indicated a willingness to attend information sessions. Of the 7158 people who gave blood during the 3-month study period, 225 (3.1%) were interested. At the time this paper was written 47 information sessions had been held, and 721 people had attended, 624 (86.5%) of whom had signed a consent form. This indicates a clear interest in a bone marrow donation program. We believe that the ethical issues are overcome by requesting the donation before identification of any patient. From our experience a national registry of unrelated donors seems feasible, and steps are being taken to implement such a program.     

Recommendations for mass spectrometry data quality metrics for open access data (corollary to the Amsterdam Principles)

Policies supporting the rapid and open sharing of proteomic data are being implemented by the leading journals in the field. The proteomics community is taking steps to ensure that data are made publicly accessible and are of high quality, a challenging task that requires the development and deployment of methods for measuring and documenting data quality metrics. On September 18, 2010, the United States National Cancer Institute convened the "International Workshop on Proteomic Data Quality Metrics" in Sydney, Australia, to identify and address issues facing the development and use of such methods for open access proteomics data. The stakeholders at the workshop enumerated the key principles underlying a framework for data quality assessment in mass spectrometry data that will meet the needs of the research community, journals, funding agencies, and data repositories. Attendees discussed and agreed up on two primary needs for the wide use of quality metrics: 1) an evolving list of comprehensive quality metrics and 2) standards accompanied by software analytics. Attendees stressed the importance of increased education and training programs to promote reliable protocols in proteomics. This workshop report explores the historic precedents, key discussions, and necessary next steps to enhance the quality of open access data. By agreement, this article is published simultaneously in the Journal of Proteome Research, Molecular and Cellular Proteomics, Proteomics, and Proteomics Clinical Applications as a public service to the research community. The peer review process was a coordinated effort conducted by a panel of referees selected by the journals.     

Development of a validation protocol to determine the ability of screw-top containers to be watertight and to withstand impact damage from accidental dropping

Polypropylene screw-top containers are used to collect, transport and store a variety of tissues within tissue banks. These containers are validated for use by tissue banks but no standard validation protocol is used. We present here a protocol for testing screw-top containers for leakage, evaporation and the ability to withstand accidental impact damage. Three different containers were tested, MedFor S072, MedFor S277 and MacoPharma PROT0483. The validation can detect differences between different manufacturer’s containers and this protocol will be used in future validations of screw-top containers within National Blood Service Tissue Services.     

Recommendations for mass spectrometry data quality metrics for open access data (corollary to the Amsterdam principles)

Policies supporting the rapid and open sharing of proteomic data are being implemented by the leading journals in the field. The proteomics community is taking steps to ensure that data are made publicly accessible and are of high quality, a challenging task that requires the development and deployment of methods for measuring and documenting data quality metrics. On September 18, 2010, the U.S. National Cancer Institute (NCI) convened the "International Workshop on Proteomic Data Quality Metrics" in Sydney, Australia, to identify and address issues facing the development and use of such methods for open access proteomics data. The stakeholders at the workshop enumerated the key principles underlying a framework for data quality assessment in mass spectrometry data that will meet the needs of the research community, journals, funding agencies, and data repositories. Attendees discussed and agreed upon two primary needs for the wide use of quality metrics: (i) an evolving list of comprehensive quality metrics and (ii) standards accompanied by software analytics. Attendees stressed the importance of increased education and training programs to promote reliable protocols in proteomics. This workshop report explores the historic precedents, key discussions, and necessary next steps to enhance the quality of open access data. By agreement, this article is published simultaneously in Proteomics, Proteomics Clinical Applications, Journal of Proteome Research, and Molecular and Cellular Proteomics, as a public service to the research community. The peer review process was a coordinated effort conducted by a panel of referees selected by the journals.     

Demography and blood donation trends in Saudi Arabia: A nationwide retrospective,cross-sectional study

BackgroundBlood product supply and utilization are understudied in Saudi Arabia. This study evaluates the trends in Saudi blood banks readiness, donors’ demography, and blood product utilization and wastage.Study design and methodsA retrospective, cross-sectional study of records obtained from the Ministry of Health (MOH) was initiated to report trends and statistics on annual whole blood donors and blood product utility from 2010 to 2020. Data collected in 2020 was further characterized for donors’ demographics, laboratory readiness, and staffing.ResultsThe average number of annual blood donors over the last decade (2010–2020) was 325,847.3 ± 43,160. The forecasted blood donation and dispatch trends suggest a significant increase in blood demand (R² = 0.7582) over annual donation rates (R² = 0.2356). In 2020, 342,460 nationwide blood donations were registered in governmental donation centers and females constituted a mere 2.5 %. Approximately 60 % of whole blood donation was voluntary, 36% was compensatory, and 4% was part of driving license renewal. The highest blood donation rate per 1,000 inhabitants was observed in Taif (69.8) and Alqonfoda (45.0). Eastern directory and Madinah had the most successful donation campaigns attracting 53% and 50% of total annual donations, respectively. Notably, Tabouk, Hai’l, and Albaha had the highest blood product wastage medians.ConclusionBlood donation rates and impetus, staffing ratios, and laboratory readiness and wastage varied among the various directories. Laboratory managers and medical directors need to increase efforts to refine current guidelines in order to comply with the transformation plan of the health sector.     

Recommendations for mass spectrometry data quality metrics for open access data (corollary to the Amsterdam Principles)

Policies supporting the rapid and open sharing of proteomic data are being implemented by the leading journals in the field. The proteomics community is taking steps to ensure that data are made publicly accessible and are of high quality, a challenging task that requires the development and deployment of methods for measuring and documenting data quality metrics. On September 18, 2010, the U.S. National Cancer Institute (NCI) convened the "International Workshop on Proteomic Data Quality Metrics" in Sydney, Australia, to identify and address issues facing the development and use of such methods for open access proteomics data. The stakeholders at the workshop enumerated the key principles underlying a framework for data quality assessment in mass spectrometry data that will meet the needs of the research community, journals, funding agencies, and data repositories. Attendees discussed and agreed up on two primary needs for the wide use of quality metrics: (1) an evolving list of comprehensive quality metrics and (2) standards accompanied by software analytics. Attendees stressed the importance of increased education and training programs to promote reliable protocols in proteomics. This workshop report explores the historic precedents, key discussions, and necessary next steps to enhance the quality of open access data. By agreement, this article is published simultaneously in the Journal of Proteome Research, Molecular and Cellular Proteomics, Proteomics, and Proteomics Clinical Applications as a public service to the research community. The peer review process was a coordinated effort conducted by a panel of referees selected by the journals.     

Tissue Banking in Australia

The legal structure for the regulation of tissue banking has existed for many years. In Australia, the donation of human tissue is regulated by legislation in each of the eight States and Territories. These substantially uniform Acts were passed in the late 1970's and early 1980's, based on model legislation and underpinned by the concept of consensual giving. However, it was not until the early 1990's that tissue banking came under the notice of regulatory authorities. Since then the Australian Government has moved quickly to oversee the tissue banking sector in Australia. Banked human tissue has been deemed to be a therapeutic good under the Therapeutic Goods Act 1989, and tissue banks are required to be licensed by the Therapeutic Goods Administration and are audited for compliance with the Code of Good Manufacturing Practice- Human Blood and Tissues. In addition, tissue banks must comply with a myriad of other standards, guidelines and recommendations.     

Development of a transplantation transmission sentinel network to improve safety and traceability of organ and tissues

The US lags behind other developed countries in creating a system to monitor disease transmission and other complications from human allograft use, despite a pressing need. The risks of transmission are amplified in transplantation, since at least 8 organs and more than 100 tissues can be recovered from a single common organ and tissue donor. Moreover, since many allografts collected in the US are distributed internationally, tissue safety is a global concern. In June 2005, participants of a US government-sponsored workshop concluded that a communication network for the tracking and reporting of disease transmissions for tissues and organs was critically needed. The United Network for Organ Sharing (UNOS) entered into a cooperative agreement with the Centers for Disease Control and Prevention (CDC) in 2006 to develop a system prototype. Over the following 3 years, the Transplantation Transmission Sentinel Network (TTSN) was developed and piloted with the participation of organ procurement organizations, tissue banks and transplant centers. The prototype centered around three elements of data entry: (1) donation, (2) tissue implantation, and (3) adverse event. The pilot proved that a system can be built and operated successfully, but also suggested that users may be hesitant to report adverse events. CDC has requested further input on scope and cost to build a transplant surveillance infrastructure for a fully functional national system. For tissues however, in contrast to organs, tracking from recovery to implantation will be necessary before a system is operable, requiring common identifiers and nomenclature. Until a US sentinel network is operational, future transmission events that are preventable may result nationally and globally due to its absence.     

Canadian heart health surveys: a profile of cardiovascular risk. Survey methods and data analysis. Canadian Heart Health Surveys Research Group.

OBJECTIVE: To describe the methods used in nine provincial surveys carried out as part of the Canadian Heart Health Initiative. DESIGN: Population-based cross-sectional surveys, following a core standardized protocol, implemented by provincial departments of health in collaboration with Health and Welfare Canada. Data were obtained through a home interview and a clinic visit. A standard manual of field operations and standardized training procedures were used in all provinces. SETTING: Nine Canadian provinces during the period 1986 to 1990. PARTICIPANTS: A probability sample of 26,293 men and women aged 18 to 74 years was selected from the health insurance registries in each province. Over 30% of the participants had post-secondary education. About 50% were 18 to 34 years old. OUTCOME MEASURES: Data on sociodemographic characteristics, hypertensive and diabetic status, knowledge and awareness of the causes and consequences of cardiovascular disease and two blood pressure measurements were obtained in a home interview. During a clinic visit, data were collected on height, weight (waist and hip circumferences in four provinces), two blood pressure measures and a blood sample. Total plasma cholesterol, triglycerides and high- and low-density lipoprotein cholesterol were measured in the Lipid Research Laboratory, University of Toronto and St. Michael''s Hospital. MAIN RESULTS: Of the subjects invited to participate in the survey, 78% were interviewed, 69% attended the clinic and 64% provided a fasting specimen (8 hours or more). The response rates were slightly lower for men aged 18 to 34, for women aged 65 to 74 and for those with fewer years of education. Data from the provincial surveys (Ontario will complete the survey in 1992) are being compiled in the Canadian Heart Health Database. CONCLUSION: The process followed in the implementation of the provincial heart health surveys is a model of how provincial departments of health may carry out epidemiologic investigations in support of their mandate. The approach illustrates how a country-wide database can be built through partnerships among different levels of government. The use of community health nurses was instrumental in the efficient implementation of the surveys and in the realization of the relatively high rates of response attained.