December 2014—Following is one section of the chapter, “Flow of Biospecimens: From the Clinic or Operating Room To and From the Biospecimen Repository,” in the new CAP Press book titled Developing and Organizing an Institutional Biospecimen Repository. Chapter authors are Daniel Rohrer, BS, MBA; David W. Chesla, PA-ASCP; and Scott D. Jewell, PhD.
Figure. Examples of kit contents (A) and packaging for shipment (B)
A widespread concern in the collection of biospecimens is the degree of variation in the collection procedures. Standardization of biospecimen collection kits is an effective way to ensure greater consistency in biospecimen collection. These kits often contain all the materials necessary to properly collect, preserve, and ship biospecimens to the biorepository. Collection kits will vary depending on the type of specimens, temperature conditions, and shipping methods. Collection kits can be used for institutional collection procedures as well because they contain the proper materials, but they are essential if the biospecimens are coming from source sites outside the institution.
The construction of kits must satisfy all applicable laws and regulations, such as the International Air Transport Association (IATA) and/or Department of Transportation regulations. Persons affiliated with the biorepository can consult these agencies for information concerning transportation regulations and the classifications of packages and specimens for shipment. In general, kits are composed of an outer corrugated shell, an inner insulated container, primary collection receptacles, packing material, and temperature-regulating materials such as dry ice or freezer packs (Figure). Kits do not generally contain surgical tools or routine receptacles used in standard-of-care surgical procedures.
Examples of biospecimen collection kit items include procurement materials, tissue cassettes, vials, tubes, cryotubes, reagents, container labels, shipping labels, and data forms. In blood collections, blood tubes can be considered for phlebotomy if the process of getting these to the phlebotomist is not in itself too complicated. Often, blood collections can rely on the blood tube supply of the phlebotomist, and a form of reimbursement can be established if needed. The standardization of biospecimen collections within an institution can be controlled better if kits are developed; however, depending on the structure of the operations, institutions may also use the existing clinical material sources (eg, phlebotomy tubes) as well as bulk supplies available to the procurement personnel.
Careful planning is necessary when determining the scheme for biospecimen labels and the subsequent downstream use. This scheme should, at a minimum, allow for a unique identifier for each “parent biospecimen” and for each “child aliquot” or derivative throughout the entire bank. Identifiers must never repeat. Care should be taken to plan for the future in allowing the scheme to grow with the bank (ie, not limiting the identifier through character length or other restrictions). The identifier should be anonymous, in that identifying information (either to the patient or the source site) should not be embedded directly in the code. Presently, bar-coded unique identifiers on labels is the standard in tracking the path of the biospecimen from collection to processing to storage to distribution. The ability to assign new biospecimen numbers to derivatives of primary specimens that do not link to the parent sample through the identifier code (rather, in the inventory system only) is of increasing value for downstream distribution to investigators. The biorepository inventory information system should contain flexible biospecimen numbering assignment capability while ensuring connectivity back to the primary biospecimen.
For institutions where tissues are transported from the OR to the pathology department, cooled containers or wet-ice buckets should be used to maintain lower temperatures to minimize cold ischemia preanalytic variables. To date, published data have not definitively determined a best practice for biospecimen analytes, but the general consensus is that controlled conditions are best. Distance and weather conditions can affect sample quality during transportation if not properly controlled. Because tissues coming from surgical procedures are still part of the clinical process, the management of the tissue specimen for research should involve the clinical and pathology departments in order to determine if deviations from the clinical practice are allowable. The same considerations may need to be given for blood collections as well, because practices in proteomics may require rapid processing to minimize degradation of proteins by proteases. After the point of collection, it is critical to hand off biospecimens to the biorepository/procurement technologist for quick processing to protect against degradation. Electronic temperature data loggers are tools that can be helpful both to assess and track the temperature conditions that biospecimens encounter, in addition to determining whether the biospecimen shipping containers are functioning as planned.
The use of collection kits must be managed, at a minimum, through the tracking of courier shipments and expiration dates of materials in the kits. This is most efficiently and effectively handled in a tracking database using unique kit identifiers, with unique identifiers for prelabeled contents linked to each kit identifier, with expiration dates and lot numbers of contents, date of shipment, associated courier tracking number, and the destination. Kits (and their contents) should be linked to a specific participant collection event. This linkage to a collection event is generally completed by the procurement technician. A tracking database allows the biorepository personnel to track the usage of the kits by source sites or internal use and maintain adequate inventory of collection supplies.
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