ng whether and at what stage leaks or cracks were detected. Record the following:
HEMACORD ID number
Date of receipt of the HEMACORD
Liquid Nitrogen Storage conditions in your facility
Date of thawing
Volume of the final product
Total nucleated cell (TNC) count, CD34+ content
Viability of the cells recovered (TNC or CD34+ cells) and the method used
Results of bacterial and fungal cultures
b.E-mail or fax a copy of the report to the New York Blood Center, Inc.
Email: ncbp@nybloodcenter.org
Fax: (718) 707-3747
c.Keep a copy for your processing lab records.
d.Return the dry shipper to the New York Blood Center, Inc. The return address is:
New York Blood Center, Inc.
National Cord Blood Program
45-01 Vernon Blvd.
Long Island City, NY 11101
Ph: (718) 706-5211
Fax: (718) 707-3741
5. EMERGENCY PRODUCT RECOVERY IN THE EVENT OF A CONTAINER FAILURE
a.To prevent accidental fracture, handle the HEMACORD bags with extreme caution when removing them from the protective metal cassettes, during inspection, and during the thawing process.
b.Perform the thawing process in a controlled laboratory environment that provides appropriate equipment and supplies for post-thaw sampling and/or bag rescue, as well as dedicated space and personnel for product preparation.
c.To mitigate the extreme temperature change from storage at -196°C (Liquid Nitrogen phase) to thawing at 38°C, and possible sudden vaporization of liquid nitrogen in recess of the bag or tubing, hold the HEMACORD bag in the vapor phase for a few minutes following removal from the liquid phase of nitrogen before removal for thawing.
d.To prevent an accidental drop onto the floor, handle HEMACORD bags over a flat surface, such as a table.
e.Place HEMACORD bags in individual sterile zipper-locked bags prior to thawing to facilitate salvage of the product and to reduce contamination in case of an unanticipated problem.
f.If the HEMACORD bag is obviously fractured upon removal from cold storage, or if it fractures during the thawing process, please notify the Processing Laboratory of the National Cord Blood Program at the New York Blood Center [phone number: 718-706-5211 or 1-866-767-NCBP (1-866-767-6227)] as soon as possible. Notify the transplant physician and the laboratory director immediately.
g.It is the transplant physician’s (or designee’s) responsibility to determine whether the HEMACORD product will be used or discarded and whether additional product(s) are to be requested for infusion.
h.If the transplant physician (or des
