The Quality Product Guarantee is not intended to guarantee the result of a medical procedure. It is intended to apply only in the event that cord blood stem cells are required for hematopoietic transplant, subject to certain exclusions defined below. In order to qualify, Mother/Donor must complete the required Enrollment Documents, including the Financial and Storage Agreement, the Donor Informed Consent and the Health History Questionnaire in entirety.
Engraftment is defined as achieving a peripheral blood absolute neutrophil count of 500 per microliter for three consecutive measurements with the first of three measurements occurring within 100 days of transplantation. The engraftment must be of donor origin.
The Quality Product Guarantee does not include:
- Cord blood units that are collected by any method outside of Maze Cord Blood’s standard operating procedure, even if such cord blood units have been stored by Maze Cord Blood with Mother/Donor’s approval.
- Transplantation of umbilical cord blood with less than 2 x 107 total nucleated cells per kilogram, even if such cord blood units have been stored by Maze Cord Blood with Mother/Donor’s approval.
- Transplantation of umbilical cord blood with less than 1 x 105 CD34+ cells per kilogram, even if such cord blood units have been stored by Maze Cord Blood with Mother/Donor’s approval.
- Co-transplant with supplemental stem cell sources (e.g., additional cord blood, peripheral blood or bone marrow).
- Transplant other than to biological family members, defined as the child/cord blood donor and his/her biological parents and biological siblings.
- Experimental transplantation, defined as any of the following: transplantation using stem cells that, prior to administration to the patient, have been subject to more than minimal manipulation (e.g., stem cell expansion, gene therapy, extensive laboratory culture or positive or negative cell selection); cells transplanted for non-homologous use; transplantation using stem cells that are subject to a US Food and Drug Administration investigational new drug application or foreign equivalent; use of an investigational drug by the transplant recipient within 100 days of transplantation.
Required documentation of failure to engraft includes: signed statement form the treating transplant physician attesting to the fact that the transplant did not engraft and all supporting laboratory reports, or Maze Cord Blood’s written notice of its inability to produce the cord blood unit for hematopoietic transplant.
The Quality Product Guarantee is not meant to cover any costs that are reimbursed by third-party payers. Prior to payment of the Quality Product Guarantee, Maze Cord Blood must have proof, in writing, that all third-party payers involved in paying for collection, storage or transplant have been notified.