Inspection of Fixed or Non-Fixed Cord Blood Collection Sites? That is the Question for FACT.
Cord blood banks accept the noble challenge of collecting what many still unfortunately consider medical waste – placental and umbilical cord blood – and transforming it into a lifesaving therapy. In many cases, this is accomplished by establishing formal relationships with specific hospitals and other birthing units, with a written agreement between the collection site and the bank for the collection of cord blood units. The agreement describes the interaction between the collection site and the bank for all aspects of the collection process including, at a minimum, personnel training, record keeping, collection, storage, and transportation or shipping of a cord blood unit.
There are also non-fixed collection sites, where the collection of cord blood is initiated by the infant donor’s mother or family. For these sites, banks must document that a health care professional has agreed to perform the collection in accordance with the cord blood bank’s collection procedures and must provide training that covers each aspect of the collection process. Cord blood collection at these sites are typically infrequent.
The NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration make very few distinctions between fixed and non-fixed collection sites, because both types have a direct impact on the quality of the cord blood unit ultimately given to a patient. Therefore, because they perform a critical step of the cord blood banking process, facilities that collect cord blood units for an applicant cord blood bank are inspected during the accreditation process.
There are several models used by cord blood banks to collect placental and umbilical cord blood, and FACT and WMDA-NetCord acknowledge the need for banks to institute models that work best for them. Banks submit information about all collection sites to FACT; with that information, FACT determines what collection sites will be inspected as part of the accreditation process. Collection sites are selected depending on a number of variables to allow verification of compliance of all processes used by the bank. Examples of variables include:
- Distance from the bank,
- Mode of transport from the collection site to the bank (e.g., private courier, donor family, commercial shipper),
- Travel time between the collection site and bank,
- Temporary storage location between the collection site and bank,
- Average number of units collected per year,
- Method of collection (in utero, ex utero, or both),
- Type of unit (e.g., unrelated allogeneic, directed allogeneic), and
- Collecting professional (e.g., bank employee, obstetrician, collection site employee).
Sometimes, cord blood banks consider a relationship with a collection site to be non-fixed, but FACT still must inspect those sites because of their responsibilities. For example, collection sites that collect a large number of cord blood units a year, store collection kits, obtain informed consent, or perform other responsibilities may be inspected. Inspectors have identified areas for improvement at such collection sites, and we believe that the processes banks implement to address these issues will result in higher quality units. Many of the deficiencies are easily resolved by the bank, and place little burden on the collection sites themselves; sometimes they make the process better for the sites. For example, a high microbial contamination rate may be attributed to the collection process. The bank can decrease the contamination rate by providing clearer Standard Operating Procedures (SOPs) and training regarding preparation of the needle site and handling of equipment.
