A Biobank's Journey: Implementation of a Quality Management System and Accreditation to ISO 20387

Mouttham, Lara; Garrison, Susan J.; Archer, Denise L; Castelhano, Marta G.

doi:10.1089/bio.2020.0068

Cited by 21 publications

(14 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…34,35 International standards have also been established, including ISO 20387:2018 General requirements for biobanking , 36,37 and these are beginning to be implemented by bioresources. 38 In addition, some bioresources may be accredited by the College of American Pathologists Biorepository Accreditation Program. 39 These best practices, standards and accreditation programmes help to ensure that the biospecimens and associated data obtained from bioresources are of high quality and fit for their intended purpose.…”

Section: How To Find An Appropriate Good Quality Bioresourcementioning

confidence: 99%

The Use of Human Tissues for Research: What Investigators Need to Know

Bledsoe

Grizzle

2022

Altern Lab Anim

View full text Add to dashboard Cite

While laboratory animals are necessary for some aspects of the development of scientific and biomedical advances, including those of precision medicine, the use of human tissues is necessary in order to explore the findings and ensure that they are relevant to human systems. Many sources of human tissues exist, but researchers — particularly those making the transition from animal to human systems — may not be aware of how best to find quality sources of human tissues or how best to use them in their research. In this article, we discuss the advantages of using human tissues in research. In addition, we highlight some of the major advances made possible through the use of human tissue, and describe how human tissue is collected for research. We discuss the various types of bioresources that make human tissue available, and advise on how investigators can find and use appropriate bioresources to support their research — with the hope that this information will help facilitate the transition from research on animals to research using human tissues, as rapidly as is practicable.

show abstract

Section: How To Find An Appropriate Good Quality Bioresourcementioning

confidence: 99%

The Use of Human Tissues for Research: What Investigators Need to Know

Bledsoe

Grizzle

2022

Altern Lab Anim

View full text Add to dashboard Cite

show abstract

“…Despite a long history, 3 biobanking is still growing. 4 A variety of tools help address quality and fitness-for-purpose in biobanking. These tools are generally aligned to four categories, as may be seen in Figure 1, and are further described below, accompanied by descriptions of specific biobanking tools:…”

Section: Toolsmentioning

confidence: 99%

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies

Allocca

Snapes²,

Albert

et al. 2020

Biopreservation and Biobanking

Self Cite

View full text Add to dashboard Cite

The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools (e.g., standards, best practices, and plans) exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force has set out to identify needs and gaps in these tools and make recommendations for the next generation of available tools, having closely examined the COVID-19-related challenges. While conducting this work to examine the relationships between tools and biobank adaptability, a subgroup of the task force conducted a parallel effort to develop and describe individual COVID-19 era case studies based on a number of operating biobanks. Each case study presents a different combination of implemented tools. Observations and lessons learned from these case studies are provided, and experiences with tool implementation are discussed. This information is supplemented by data relating to tool usefulness that was obtained through an ISBER survey discussed in a companion article. The knowledge gained from this study will be combined with other task force efforts to make recommendations to better position the biobanking community in their response to future emergencies.

show abstract

“…Today, biobanks are called to move forward from the certification scheme ISO 9001:2015 [ 2 ] to the ISO 20387:2018 accreditation scheme, called General requirements for biobanking [ 3 , 4 ]. This standard was developed with the objective of promoting confidence in biobanking.…”

Section: Introductionmentioning

confidence: 99%

Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari

Palma

Bolondi²,

Tufaro

et al. 2022

Cancers

View full text Add to dashboard Cite

Although research biobanks are among the most promising tools to fight disease and improve public health, there are a range of risks biobanks may face that mainly need to be assessed in an attempt to be relieved. We conducted a strategic insurance review of an institutional cancer biobank with the aim of both identifying the insurable risks of our own Biobank and gathering useful evidence of primary exposure to insurable risks. In this practical scenario, risks have been outlined and categorized into inherent and residual risks, along with their possible impact on biobank maintenance. Results at the Biobank of the Cancer Institute of Bari showed evidence of potentially significant and intrinsic risk due to highly relevant threats, along with already implemented improvements that significantly reduce risks to a range of relative acceptability.

show abstract

A Biobank's Journey: Implementation of a Quality Management System and Accreditation to ISO 20387

Cited by 21 publications

References 24 publications

The Use of Human Tissues for Research: What Investigators Need to Know

The Use of Human Tissues for Research: What Investigators Need to Know

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies

Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari

Contact Info

Product

Resources

About