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Traceability.

Ashford P - Cell Tissue Bank (2010)

Bottom Line: In particular there is: a lack of appreciation of the complexity of the traceability pathway; a fragmented approach to traceability; and, an assumption that traceability data is static.Whilst responsibility within each organization may be clearly defined, responsibility for maintaining the interfaces between organizations is often less clear.End to end traceability audits are not routinely performed, and the only true test of the trail occurs when recall is required-often with inadequate results.

View Article: PubMed Central - PubMed

Affiliation: International Council for Commonality in Blood Banking Automation, San Bernardino, CA 92423-1309, USA. paul.ashford@iccbba.org

ABSTRACT
The importance of effective and timely traceability in both the recall of substances of human origin (blood, cells, tissues and organs) implicated in infectious transmission, and in the prevention of inappropriate use of substances of human origin is now well recognised. However, traceability remains poorly understood and inadequately controlled in many cases. In particular there is: a lack of appreciation of the complexity of the traceability pathway; a fragmented approach to traceability; and, an assumption that traceability data is static. The traceability path for a single tissue donor may involve dozens or even hundreds of different organizations, each responsible for one segment of the path. Whilst responsibility within each organization may be clearly defined, responsibility for maintaining the interfaces between organizations is often less clear. Traceability is seldom regarded in a holistic manner, the assumption being made that if each segment of the pathway is correctly maintained then the full path will be intact. End to end traceability audits are not routinely performed, and the only true test of the trail occurs when recall is required-often with inadequate results.

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Related in: MedlinePlus

Simplified example of organ and tissue recovery from a single donor
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Related In: Results  -  Collection


getmorefigures.php?uid=PMC3012211&req=5

Fig1: Simplified example of organ and tissue recovery from a single donor

Mentions: Figure 1 illustrates a very simplified example of organ and tissue recovery from a deceased donor, but even with this simple model there are likely to be between 12 and 20 different organizations involved in the traceability trail. Where many hundreds of tissue products are prepared, and where distributors are involved as well as tissue banks, the number of organization could easily run into the hundreds. Such a situation may exist where highly processed bone is produced in a large number of small packs for dentistry applications.Fig. 1


Traceability.

Ashford P - Cell Tissue Bank (2010)

Simplified example of organ and tissue recovery from a single donor
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3012211&req=5

Fig1: Simplified example of organ and tissue recovery from a single donor
Mentions: Figure 1 illustrates a very simplified example of organ and tissue recovery from a deceased donor, but even with this simple model there are likely to be between 12 and 20 different organizations involved in the traceability trail. Where many hundreds of tissue products are prepared, and where distributors are involved as well as tissue banks, the number of organization could easily run into the hundreds. Such a situation may exist where highly processed bone is produced in a large number of small packs for dentistry applications.Fig. 1

Bottom Line: In particular there is: a lack of appreciation of the complexity of the traceability pathway; a fragmented approach to traceability; and, an assumption that traceability data is static.Whilst responsibility within each organization may be clearly defined, responsibility for maintaining the interfaces between organizations is often less clear.End to end traceability audits are not routinely performed, and the only true test of the trail occurs when recall is required-often with inadequate results.

View Article: PubMed Central - PubMed

Affiliation: International Council for Commonality in Blood Banking Automation, San Bernardino, CA 92423-1309, USA. paul.ashford@iccbba.org

ABSTRACT
The importance of effective and timely traceability in both the recall of substances of human origin (blood, cells, tissues and organs) implicated in infectious transmission, and in the prevention of inappropriate use of substances of human origin is now well recognised. However, traceability remains poorly understood and inadequately controlled in many cases. In particular there is: a lack of appreciation of the complexity of the traceability pathway; a fragmented approach to traceability; and, an assumption that traceability data is static. The traceability path for a single tissue donor may involve dozens or even hundreds of different organizations, each responsible for one segment of the path. Whilst responsibility within each organization may be clearly defined, responsibility for maintaining the interfaces between organizations is often less clear. Traceability is seldom regarded in a holistic manner, the assumption being made that if each segment of the pathway is correctly maintained then the full path will be intact. End to end traceability audits are not routinely performed, and the only true test of the trail occurs when recall is required-often with inadequate results.

Show MeSH
Related in: MedlinePlus