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PubMed2006

[Development of modern tissue banks and quality control].

OBJECTIVE: To review the development and quality control of modern tissue banks. METHODS: The rules, regulations and the management literatures about tissue banks were extensively and comprehensively reviewed. RESULTS: Tissue banks have a significant progress and are developing to concentration, industrialization and standardization gradually. Quality control is being paid more attention in modern tissue banks. CONCLUSION: Modern tissue banks will have a good future and the quality control must be intensified.

Blood Banks↗
PubMed2000

American association of tissue banks: a historical reflection upon entering the 21st century.

The American Association of Tissue Banks (AATB) is a scientific, not-for-profit, peer-group organization founded in 1976 to facilitate the provision of transplantable tissues of uniform high quality in quantities sufficient to meet national needs. The Association was created well before there was governmental oversight of tissue banking. The organization consists of individuals involved in tissue banking, medical users, and scientists in the field. Current structure consists of a 13-member Board of Governors with specific subgroups including Musculoskeletal, Reproductive, Skin, Tissue Bank Councils and Council of Accredited Tissue Banks. A historical review shows the evolution from development of guidelines to publication of standards, and from an inspection conducted by peers to one conducted by an independent, trained professional inspector. Association growth and historical accomplishments are highlighted.

Journal Article↗
PubMed2000

Quality issues in tissue banking: quality management systems - a review.

The situation in tissue banking changed radically and fundamentally at the beginning of the 1990s. The essential causes are on the one hand, the continually increasing demand for human cells and tissue and other biological material for clinical use and research, and on the other hand, the rapid progress in the medical, technical and natural sciences. Biotechnology in particular, has profited from this. Modern tissue banks could no longer be imagined without its methods.A consequence of these developments and a prerequisite for the fulfilment of the derived requirements is the necessity for national and international cooperation as well as the harmonisation of ethical principles and quality assurance standards and regulations (von Versen (1999) Ann Chir Gynaecol 88: 215-220). The introduction of an all-encompassing Quality Management System (QMS) is a suitable instrument for this purpose.After the presentation of explanations and definitions of quality terminology, this article describes the use of the international standard ISO 9000 as a general QMS, which embraces both the specific methodology as well as the general aspects of Quality Management (research and development, design control, education and training, documentation, traceability, management control, corrective action, etc.) in tissue banking. The individual elements of this system are explained and selected examples are described. The authors look upon this QMS as an indispensable instrument for harmonisation and international cooperation in tissue banking.Finally, the use of such a standard would be a positive sign to the regulatory authorities and the public that tissue banking is making a visible effort to introduce a world-class QMS in its operations.

Journal Article↗
PubMed2003

The tissue bank at the national nuclear research institute in Mexico.

The Instituto Nacional de Investigaciones Nucleares (ININ, The National Nuclear Research Institute) received during 1997-1998 strong support of the International Atomic Energy Agency (IAEA), to establish the first and only one tissue bank (BTR ININ tissue bank) in Mexico that uses ionising radiation as sterilising agent. In that time, the BTR staff was trained in different tissue banks in several countries. Basic equipment for tissue processing donated by the IAEA was received in 1998. In July, 1999 the Mexican Health Secretariat gave the Sanitary License No. 1062000001 to the BTR to operate as an official organ and tissue bank. In August, 2001 the ININ and the Hospital Materno Infantil (HMI-ISSEMYM) signed an agreement to collaborate in amnion processing. The hospital is responsible for donor selection, serology tests, tissue procurement and washing, since this hospital is the BTR amnion supplier. The tissues are collected by ININ weekly with complete documentation. The BTR is responsible for processing: cleaning, air drying, packaging, labelling, microbiological control and sterilisation by gamma irradiation. The sterilised tissue is kept under quarantine for 6 months to obtain the results of the donor second serology test. From March to June, 2002 the BTR has processed 347.86 units (50 cm(2) each), is say, 17,393 cm(2). In addition, the pig skin xenograft process has been implemented and a protocol for clinical applications of it is running at the Hospital Central Sur de Alta Especialidad (PEMEX). Also the ININ tissue bank present status and perspectives are described.

Journal Article↗
PubMed1997

Practical issues in tissue banking.

Medical and hospital facilities, including hospital blood banks, may be involved in various aspects of tissue banking. A key issue in running a successful tissue bank is understanding the scope of activity performed. The steps involved in collection, processing, storage, and distribution are reviewed, and potentially applicable rules and regulations and practical issues of tissue banking are discussed. In addition, "industry" standards that focus on storage and distribution of tissue for transplantation are summarized.

Blood Banks↗
PubMed2004

Automated clinical annotation of tissue bank specimens.

Modern, molecular bio-medicine is driving a growing demand for extensively annotated tissue bank specimens. With careful clinical, pathologic and outcomes annotation, samples can be better matched to the research question at hand and experimental results better understood and verified. However, the difficulty and expense of detailed specimen annotation is well beyond the capability of most banks and has made access to well documented tissue a major limitation in medical re-search. In this context, we have implemented automated annotation of banked tissue by integrating data from three clinical systems--the cancer registry, the pathology LIS and the tissue bank inventory system--through a classical data warehouse environment. The project required modification of clinical systems, development of methods to identify patients between and map data elements across systems and the creation of de-identified data in data marts for use by researchers. The result has been much more extensive and accurate initial tissue annotation with less effort in the tissue bank, as well as dynamic ongoing annotation as the cancer registry follows patients over time.

Clinical Laboratory Information Systems↗
PubMed2000

Cardiovascular tissue banking in the non-cadaveric setting: ten-year experience of a university hospital-based bank with active organ donation program.

BACKGROUND AND AIM OF THE STUDY: Today, transplantation of cardiovascular tissues is common practice, and tissue banking has become routine. Consequently, many institutions exist which carry out high-quality tissue banking. METHODS: The Hospital Clinico of the University of Barcelona established its cardiovascular tissue bank in 1989. The bank follows international and national regulations, and functions as a non-profit-making organization. Organ and tissue donors are recruited by the Transplant Coordination unit, which works closely with the Catalonian Organ Transplant Network (OCAT) and the Spanish National Organ Transplantation Network (ONT). The hearts are removed during multi-organ donation and processed using aseptic techniques in a laminar flow hood. Hearts are only accepted from brain-dead multiorgan and non-beating-heart donors. The heart valves are dissected, decontaminated, cryopreserved in specific media and stored in liquid nitrogen at -196 degrees C under strict bacteriological and serological control. RESULTS: Between 1989 and 1999, a series of 1,005 cardiovascular donors from within Spain was identified, from which 840 hearts were processed. After evaluation, 1,099 (65.4%) valves were cryopreserved, and 1,023 (61.5%) given clearance for implantation. In total, 534 aortic, 530 pulmonary, 33 mitral and two tricuspid valves were processed; ultimately 92.8% of aortic and 93.9% of pulmonary valves were accepted for clinical implantation. The rejection rate was 39.1%. Homografts were transported to their destination in dry ice in a cryogenic container. Overall, 608 valves were implanted at our own institution and at hospitals in Barcelona and Europe. Only two cases of complaint were received from implanting surgeons. CONCLUSION: After ten years' experience, the degree of satisfaction of implanting surgeons appears to be adequate. Strict control of the entire tissue banking process has permitted the availability of high-quality homografts for clinical implantation.

Blood Vessels↗
PubMed1993

Development of the National Marine Mammal Tissue Bank.

The National Marine Mammal Tissue Bank (NMMTB) has been established as part of a comprehensive effort to obtain reliable information on contaminant levels in marine mammal tissues. A four component program consisting of the NMMTB, stranding networks, monitoring and quality assurance has been developed. The development and current status of the NMMTB and its relationship to the other three components will be described.

Animals↗
PubMed2002

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.

Journal Article↗
PubMed2007

The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system.

UNLABELLED: Tissue banking is a complex operation concerned with the organisation and coordination of all the steps, that is, from donor selection up to storage and distribution of the final products for therapeutic, diagnostic, instruction and research purposes. An appropriate quality framework should be established in order to cover all the specific methodology as well as the general aspects of quality management, such as research and development, design, instruction and training, specific documentation, traceability, corrective action, client satisfaction, and the like. Such a framework can be obtained by developing a quality management system (QMS) in accordance with a suitable international standard: ISO 9001:2000. This paper presents the implementation process of the tissue bank QMS at the Instituto Nacional de Investigaciones Nucleares in Mexico. OBJECTIVE: The objective of the paper is to share the experience gained by the tissue bank personnel [radiosterilised tissue bank (BTR)] at the Instituto Nacional de Investigaciones Nucleares (ININ, National Institute of Nuclear Research), during implementation of the ISO 9001:2000 certification process. At present, the quality management system (QMS) of ININ also complies with the Mexican standard NMX-CC-9001:2000. The scope of this QMS is Research, Development and Processing of Biological Tissues Sterilised by Gamma Radiation, among others.

Animals↗
PubMed1999

Supplying commercial biomedical companies from a human tissue bank in an NHS hospital--a view from personal experience.

NHS histopathology laboratories are well placed to develop banks of surgically removed surplus human tissues to meet the increasing demands of commercial biomedical companies. The ultimate aim could be national network of non-profit making NHS tissue banks conforming to national minimum ethical, legal, and quality standards which could be monitored by local research ethics committees. The Nuffield report on bioethics provides ethical and legal guidance but we believe that the patient should be fully informed and the consent given explicit. Setting up a tissue bank requires enthusiasm, hard work, and determination as well as coordination between professionals in the NHS trust and in the commercial sector. The rewards are exiting new collaborations with commercial biomedical companies which could help secure our future.

Costs and Cost Analysis↗
PubMed1978

[Consulting office tissue banks (author's transl)].

The technicalities of obtaining graft tissues and the methods of preserving homograft ossicles and cartilage are described. The chemical and biological problems of tissue banks are discussed practically in relation to published experiences of others. The techniques for use of homograft ossicles in tympanoplasty surgery are described. The comparative ease of preparation and preservation of homograft ossicles and hyaline cartilage justifies the establishment of tissue banks in the practice of the private otologist.

Cartilage↗
PubMed2002

Minimax two-stage-designs with applications to tissue banking case-control studies.

'Tissue banks' are created, at least in part, to help medical scientists learn about disease biology on the basis of samples provided by patients on treatment protocols that were competed years earlier. The bank inventory consists of precious non-renewable patient material (such as frozen diagnostic blood or bone marrow), which can be linked to both clinical data and long term follow-up information. Case-control studies, where cases represent clinical failures and controls clinical successes, are ideal for rapidly learning if a laboratory marker might have prognostic significance. While group sequential (multi-stage) methods are widely used in clinical trials, they have rarely been applied in case-control studies. Further, unlike clinical trials where safety and efficiency may actually be in conflict, case-control studies can focus on efficiency. Hence, minimizing the expected sample size is a desirable goal in such a setting. Since the true effect size is never known, and since no prior distribution can be postulated for the effect size, we have opted for the minimax solution. A strategy is developed to determine amongst all two-stage designs with given type I and type II errors, the one for which the maximum expected sample size is minimized. The user is provided with simple tables, whereby one can determine everything necessary to conduct the study from the corresponding calculation for a single-stage design. A matched pair example is given where the suggested design can be modified, to obtain a superior 'two-plus' stage design. The basic idea is to conduct the first stage as planned, but use the estimate of variance to redesign the study, without using the estimate of effect size in the redesign.

Biomarkers, Tumor↗
PubMed2000

[Quality plan of a bone tissue bank].

In 1994, the French bioethics laws changed the regulations concerning donated human tissues with safety precautions and therapeutic use. The decree of 29(th) December 1998 describes the practical obligations required of bone tissue banks for approval by the French Health Ministry. Before the new regulations, a quality system was implemented at the Cochin hospital bone tissue bank. It integrates quality control for each step of the general process. We describe the quality plan of the Cochin Hospital bone tissue bank and show that the specific quality practices, resources and sequence of activities improve distribution of human bone allografts while maintaining their traceability.

Bioethics↗
PubMed1999

[Functioning of a bone tissue bank in 1998].

Last few years, the french legislation and reglementation concerning donated human tissues, safety precautions, and human tissues' uses have been deeply modified. Therefore, tissue banks' organisation, processing of allograft tissue, and the way surgeons use frozen bone graft have changed. Accordingly, authors describe different obligations these activities implicate and practical consequences for tissue banks and surgeons. First, they recall 94' laws and the doctrinal and ethical principles essential to understand current laws and official standards. Then, they specify sanitary rules all tissue banks have to conform to. They detail the different approaches to recovery, processing, preservation and distribution of transplantable bone tissue and expose modalities of the financing by social organisms. It follows practical consequences in bank functioning: supplying, importation, internal organization. In conclusion, authors synthesize surgeon's responsibilities in that specific activity.

Bone Banks↗
PubMed2006

The International Atomic Energy Agency (IAEA) program on radiation and tissue banking: a successful program for developing countries.

Since its inception the IAEA program in radiation and tissue banking supported the establishment of twenty five tissue banks in different countries. Now more than 103 tissue banks are now operating in these countries. The production of sterilized tissues has grown in an exponential mode within the IAEA program. From 1988 until the end of 2000 the production of sterilized tissues was 224,706 grafts, with an estimated value of at least $51,768,553 million dollars at the mean current charge rate in non-commercial banks in Europe and USA. During the period 1997-2002 several countries from Asia and the Pacific region produced more than 155,000 grafts, with an estimated value of about $36.7 million dollars. Training was considered to be one of the most important tasks to be supported. A total of 192 students were registered in the training program and 146 students graduated with a University Diploma. For many developing countries an additional benefit is not having to import expensive sterilized tissues from developed countries, but the exposure of orthopedic and plastic surgeons working, to new methods of using allografts in specific surgical treatments.

Developing Countries↗