ViaCord Quality Product Guarantee (QPG)
The details below can also be found in ViaCord’s Service Agreement. Upon storage of the Cord Blood Stem Cells, by ViaCord, ViaCord will support the Quality Product Guarantee (QPG) as outlined below.
Definition of Engraftment
For purposes of this QPG, “Engraftment” is defined as achieving a peripheral blood absolute neutrophil count of 500 per microliter for three consecutive measurements with the first of the three measurements occurring within 100 days of transplantation. The engraftment must be donor origin. Exclusions. The Quality Product Guarantee does not include or apply to:
- Any use of Cord Tissue Stem Cells.
- Cord Blood Stem Cells collected and/or processed by any method outside of ViaCord’s standard operating procedure, even if such cord blood units have been stored by ViaCord with the Account Owner’s approval.
- Transplantation of less than 2x10⁷ total nucleated cells per kilogram, even if the Cord Blood Stem Cells have been stored by ViaCord with the Account Owner’s approval.
- Transplantation of less than 1x10⁵ CD34+ cells per kilogram, even if the Cord Blood Stem Cells have been stored by ViaCord with the Account Owner’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. Biological family members are defined as the child (i.e., the cord blood donor) and his/her biological parents and biologicalsiblings.
- Experimental uses, defined below as any of the following: o Transplantation using stem cells that prior to administration to the patient, have been subject to manipulation including, but not limited to the following:
- Stem cell expansion.
- Extensive laboratory culture or positive or negative cell selection.
- Gene therapy.
- Transplantation using stem cells that are subject to a US Food and Drug Administration investigational new drug application or foreign equivalent.
- Use of investigational drug by the transplant recipient within 100 days of transplantation.
- Cells transplanted for non-homologous use.
- Any regenerative uses.
- The Quality Product Guarantee is not available if the stem cell collection, storage or transplant fees are paid in full or part by private or governmental insurance or healthcare programs, including, but not limited to, Medicare or Medicaid.
- Unsuccessful processing and/or storage of Newborn Stem Cells due to any problems or failures in the collection, transportation, testing, cryopreservation, or initial storage process.
- Several external factors such as delays in transportation, extreme temperatures, and improper collection are beyond the control of ViaCord and the QPG shall not apply to unavailability of Newborn Stem Cells attributable to any such external factor.
Required Documentation of Failure to Engraft
Either of the following is required documentation of failure to Engraft: (i) a signed statement from the treating transplant physician attesting to the fact that the transplant did not engraft as described above and supporting laboratory reports or (ii) ViaCord’s written notice of its inability to produce the cord blood unit for hematopoietic transplant.
Notification of Insurance
By accepting payment under the Quality Product Guarantee, the Client agrees to notify any third party payer who paid in part or wholly for the collection, storage, or transplant, of the existence of this QPG, the amount paid and all other terms and conditions. Prior to payment of the QPG, ViaCord must have proof, in writing, that all third-party payers involved in paying for collection, storage or transplant have been notified.
Additional Information
Although the preservation and potential use of umbilical cord blood is expanding rapidly, the odds that a family without a defined risk will ever use their child’s Newborn Stem Cells are low and it may never be needed. There is no guarantee that the Newborn Stem Cells will be a match for any particular family member or that a cord blood transplant will provide a cure. As with any transplant therapy, therapeutic success depends upon many factors beyond the cord blood stem cells themselves including patient condition, type of disease, recipient-donor relationship and matching, and other factors. The decision to use stored cord blood stem cells for transplantation must be made in careful consideration with a treating physician. All communication regarding Quality Product Guarantee must be in writing to: ViaCord, LLC, 77 4th Avenue, Waltham, MA 02451, Re: ViaCord Pledge.