0 |
Preamble
|
0.1 |
The technicians can constitute three advantages of storing biospecimen in the local centralized biobank to other clinical personnel. |
0.2 |
The technicians can explain the difference between pseudonymization (de-identification with link) and anonymization (de-identification without link). |
0.3 |
The technicians can illustrate basic aspects of ethical and legal issues for acquiring, storing, and releasing biospecimen. |
0.3.1 |
The technicians can report the general content of an informed consent and can describe how to act according to the donor’s will. |
0.3.2 |
The technicians can explain what needs to be done with biospecimen in case of a withdrawal of the informed consent. |
1 |
General aspects of entry, transport, storage, and processing of biospecimen
|
1.1 |
The technicians can list pre-analytical factors that influence the quality of solid and liquid biospecimen. |
1.1.1 |
The technicians can name factors that negatively influence the stability, integrity, and concentration of RNA and DNA. |
1.1.2 |
The technicians can name quality assurance aspects for the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
1.1.3 |
The technicians can evaluate the biospecimen quality based on GBA quality parameters. |
2 |
Entry of biospecimens
|
2.1 |
The technicians can illustrate how to label a sample in an appropriate way (different ways of labelling, e.g., adhesive labels, labelling by handwriting, barcodes). |
2.2 |
The technicians can explain and apply the most important aspects of data protection regarding the labelling of biospecimen. |
2.3 |
The technicians can explain mandatory aspects of documentation concerning the biospecimen entry. |
2.3.1 |
The technicians can explain “cold and warm ischemia time” and why these factors are critical for tissue quality. |
2.3.2 |
The technicians can elucidate which processing times are relevant for the processing of blood and why these times are critical for the biospecimen quality. |
2.3.3 |
The technicians can explain the HIL-index. |
3 |
Processing of biospecimens
|
3.1 |
The technicians can name the optimal processing temperatures (until the biospecimen storage entry) for the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
4 |
Storage Entry
|
4.1 |
The technicians can depict the single steps of storage entry with regard to the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
4.2 |
The technicians can explain which method of freezing is most appropriate for which of the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
4.3 |
The technicians can describe the safety measures that have to be applied when transporting biospecimen using liquid nitrogen. |
4.4 |
The technicians can apply the safety measures when transporting biospecimen using liquid nitrogen (implementation within the on-Site Training #2). |
5 |
Storage
|
5.1 |
The technicians can depict advantages and disadvantages of different storage equipment for the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
5.2 |
The technicians can depict which factors influence the quality of biospecimens during long-term storage. |
5.2.1 |
The technicians can explain the influence of the storage temperature on biospecimen. |
5.2.1 |
The technicians can describe how they ensure that the biospecimen is not exposed to temperature fluctuations during transport from one storage area to another. |
6 |
Release
|
6.1 |
The technicians can explain the framework prerequisites that have to be fulfilled for releasing biospecimen. |
6.2 |
The technicians can describe the process of releasing biospecimen. |
6.2.1 |
The technicians can describe how the six most common types of biospecimen need to be handled for transport to ensure the biospecimen quality (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
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(a)–The technicians can describe what should be added to the correctly packed parcel for quality reasons. |
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(b)–The technicians can explain the correct identification mark of the packaging for the six most common types of biospecimen for transport/shipping (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
7 |
Analysis before release
|
7.1 |
The technicians can depict the thawing protocols of the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC) with regard to the planned biospecimen usage. |
7.2 |
The technicians can list what kind of biospecimen is suitable for the most common types of analyses. |
7.2.1 |
The technicians can explain histological and immunohistochemical techniques for tissue processing. |
7.2.2 |
The technicians can outline (and perform) the process of generating tissue slices. |
8 |
Error Management
|
8.1 |
The technicians can describe what to do when the wrong label or no label is attached to a biospecimen sample tube. |
8.2 |
The technicians can give at least one recommendation to avoid errors when entering the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC) samples into storage. |
8.3 |
The technicians can explain how to avoid disturbing factors (e.g., ice formation when storing in liquid nitrogen and the entry of carbon dioxide into the biospecimen sample) when entering and retrieving biospecimen into/from the store. |
8.4 |
The technicians can give at least one recommendation to avoid errors when retrieving the six most common types of biospecimen (tissue, urine, serum/plasma, whole blood, RNA/DNA, PBMC). |
9 |
Quality Management
|
9.1 |
The technicians can explain general aspects and approaches of a quality management system for biobanking. |
9.2 |
The technicians can describe how Standard Operating Procedures (SOPs) for storage entry, processing, storage, release, and transport of biospecimen are structured. |
9.3 |
The technicians can describe and execute the emergency plan for biospecimen storage. |