Quality Guarantee

Our commitment is to provide every client with a viable source of stem cells that will result in the best treatment outcomes should they ever be needed. We stand behind our products 100% and back our commitment with the highest Quality Guarantee in the Cord Blood Banking industry.

Quality Guarantee

Our guarantee states that if your child’s cord blood stem cells fail to engraft during a transplant due to a product defect, we will replace them with a suitable match from our public banking inventory. Should a suitable match not be available, we will pay up to $100,000 to defray the cost of procuring an alternative stem cell source as determined by your doctor.

Terms & Conditions

This Quality 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 the exclusions that are noted below.

In addition, the Quality Guarantee will not be extended to the Parent(s) unless the Parent(s) has completed and returned to Cord for Life^® both Client Contract and the Health History Questionnaire.

Subject to the requirements set forth below, if a Client’s cord blood is processed and stored by Cord for Life^® and is used for hematopoietic stem cell transplantation using recognized medical practices and fails to engraft, Cord for Life^® will pay the Parent(s) $100,000. This payment to the Parent(s) is intended to partially defray the costs to procure alternative stem cells from a public cord blood bank, in the event of product failure.

Definition of Engraftment:

Engraftment is defined as three consecutive measurements in which the transplant recipient’s peripheral blood absolute neutrophil count (ANC) is equal to or greater than 500/microliter with the first measurement occurring within 100 days of transplantation. The engrafted cells must be of donor origin.

Requirements

In order to qualify, Client must complete and return the required Enrollment Packet, including the Enrollment Agreement, the Informed Consent, the Payment Plan Form and Credit Card Authorization, and the Health Questionnaire in entirety.

Required documentation of failure to engraft includes:

1. Signed statement from the treating physician attesting that the transplanted donor product did not engraft.
2. Laboratory records documenting proof of non-engraftment.
3. Written documentation that all third party payers involved in paying for collection, storage or transplant have been notified and declined coverage.
4. Or, Cord for Life^®’s written notice of its inability to produce the cord blood unit for hematopoietic transplant.

HLA tissue typing: donor cells must be at least a 4 out of 6 match to the recipient.

The cord blood thawing procedure must be a validated procedure used by the transplant facility and the cord blood must be administered immediately (within 1 hr) upon thawing.

The cryopreserved cord blood must be used in an autologous stem cell transplant for homologous use (hematopoietic reconstitution) by the donor or by a first-degree or second-degree blood relative (the “Immediate Family”). The cryopreserved cord blood must be administered under the direction of a transplant physician in a FACT accredited medical facility qualified by an Institutional Review Board (IRB) for stem cell transplantation. 


Exclusions:

The Quality Guarantee does not include:

1. Cord blood units that are collected by any method outside of Cord for Life^®’s standard operating procedure, even if such cord blood units have been stored by Cord for Life^® with Parent(s)’approval. 

2. Transplantation of umbilical cord blood with less than 2 x 107 total nucleated cells per kilogram of recipient’s weight, even if such cord blood units have been stored by Cord for Life^® with Parent(s)’ approval. 

3. Transplantation of umbilical cord blood with less than 1 x 105 CD34+ cells per kilogram of recipient’s weight, even if such cord blood units have been stored by Cord for Life^® with Parent(s)’ approval. 

4. Co-transplant with supplemental stem cell sources (e.g., additional cord blood, peripheral blood or bone marrow). 

5. Transplantation 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 biological siblings. 

6. Experimental transplantation protocols, defined below as any of the following: 

   • Mini –transplants
   • Transplantations using stem cells that, prior to administration to the patient, have been subject to more than minimal 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 an investigational drug by the transplant recipient within 100 days of transplantation.
   • Cells transplanted for non-homologous use.

The Quality Guarantee is not available to:

• The Quality Guarantee is not meant to cover any costs that are reimbursed by Third Party Payors, including, but not limited to the following:
• Individuals whose cord blood stem cell collection, storage, or transplant fees are paid in full or part by Medicare, Medicaid, Blue Cross/Blue Shield or other commercial insurance company the is the payor for coverage provided by a health plan.
• Individuals whose cord blood stem cell collection, storage, or transplant fees are paid in full or part by third-party payors in Massachusetts and Michigan.

Notification of Insurance:

By accepting payment via the Cord for Life^® Quality Guarantee, the recipient agrees to notify any third-party payor who paid in part or wholly for the collection, storage, or transplant, of the existence of this Quality Guarantee, the amount paid and all other terms and conditions. Prior to payment of the Quality Guarantee, Cord for Life^® must have proof, in writing, that all third-party payers involved in paying for collection, storage or transplant have been notified.

Additional Information:

This $100,000 ® Quality Guarantee is valid for Clients who have signed Cord for Life^®’s standard contract and Agreement covering cord blood services and whose payments to Cord for Life^® for services are current.

Any and all payments made by Cord for Life^® under the Quality Guarantee are made at the sole discretion of Cord for Life^®.

The guarantee only covers the cost of procuring replacement stem cells and does not cover the cost of medical procedures or other related fees.

Any applicable federal, state or local taxes associated with the payments defined herein are the sole responsibility of the Client. 

Client should note that banking a newborn’s cord blood does not guarantee that the umbilical cord blood will be a match for a family member, that a cord blood stem cell transplant would be the first or best course of treatment for any particular disease or that a child’s own cord blood is useful for every disease treatable by stem cell transplantation. A medical care provider ultimately decides whether the use of your Child’s cord blood sample is indicated, based on the nature and progression of the disease and the HLA matching for donor and recipient. This offer is independent from and in no way diminishes the effect of Cord for Life^®’s limitation of liability set forth in its Agreement with client. 


This $100,000 Cord for Life^® Quality Guarantee is available only to Clients enrolling under the new service Agreement and associated fee structure beginning on or about May 1, 2018. The Cord for Life^® Quality Guarantee is not retroactive to enrollments occurring before May 1, 2018.