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. 



LATEST ARTICLES


October 29, 2021

Cord for Life® ANNOUNCES CORD BLOOD CLINICAL TRIAL Phase I Trial for the Treatment of lower back pain of the Sacroiliac Joint ALTAMONTE SPRINGS, FL (October 29, 2021) Cord for Life®®, a full-service cord blood bank with over 25 years of experience, today announced plans to conduct a clinical trial to treat lower back pain arising from the Sacroiliac Joint (SIJ) using a biological therapeutic derived from umbilical cord blood. The company has […]

August 27, 2020

The results of a Phase I study published in Stem Cell Translational Medicine suggest that it is safe and feasible to infuse stem cells from banked umbilical cord blood into adults following an acute ischemic stroke. This research paves the way for additional studies into the efficacy of umbilical cord blood in treating stroke patients. […]

August 6, 2020

The human umbilical cord is being increasingly recognized by the medical community for its potential in regenerative medicine and cellular therapies. Once discarded as medical waste, the umbilical cord contains valuable stem cells that are now at the forefront of medical research.  Cord blood derived Hematopoietic  Stem Cells (HSCS) are currently approved by the FDA and being used to treat over 80 diseases and cord tissue derived therapies have been approved in the […]

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Our purpose is to provide the expectant mothers with information necessary to discover the lifesaving potential of umbilical cord blood.

Copyright Cord for Life 2019. All rights reserved.

Deborah A. Sardone

Ms. Sardone has over 30 years of clinical laboratory experience as a Clinical Laboratory Technologist and Supervisor, including over 25 years with Central Florida Regional Hospital (CFRH). She was Supervisor of Quality Assurance, Safety and Education at CFRH for 11 years, held the positions of Blood Bank Supervisor for 11 years, and Hematology Supervisor for 1 year. She has participated in both sides of the inspection process, serving on the College of American Pathologists Inspection team for CAP Hospital Accreditation in Florida, and assisting in receiving accreditation by The Joint Commission (TJC), American Association of Blood Banks (AABB), and Food and Drug Administration (FDA) through the inspections of the clinical laboratory. Ms. Sardone is licensed by the State of Florida as a Clinical Laboratory Technologist in Immunohematology, Hematology, Serology and Clinical Chemistry. She is a certified Clinical Laboratory Technologist with the American Society of Clinical Pathologists (ASCP). Ms. Sardone serves as Manager of Quality Assurance and Regulatory Affairs at Cord For Life, Inc. overseeing all licensing and regulatory agencies to ensure that the highest quality in all aspects of cord blood collection, processing, and storage is maintained.  Ms. Sardone has been with Cord For Life for over 5 years of dedicated service. Her skills and knowledge in blood banking and quality assurance have enabled her to establish, implement and maintain a superior quality system that meets and exceeds all standards and regulatory requirements for Cord For Life, Inc.

Personal Background:

  • Sardone is a graduate of The City University of New York in Medical Laboratory Technology.
  • Sardone is licensed in Florida as a Clinical Medical Technologist and she is nationally recognized as ASCP Certified.
  • Sardone enjoys photography and dancing.

Donald Hudspeth

Mr. Hudspeth has over 28 years of clinical laboratory experience as a certified Medical Technologist (ASCP), including ten years with the University of North Carolina Hospitals and 18 years with Cord for Life. Mr. Hudspeth is licensed by the State of Florida as a Clinical Laboratory Supervisor in Immunohematology, Hematology, Serology, Clinical Chemistry, Molecular Pathology and Microbiology as well as a Clinical Laboratory Scientist and has completed the AABB Certification in Cellular Therapies through George Washington University.

Mr. Hudspeth is a registered Technologist with the American Society of Clinical Pathologists and a member of the Cord Blood Association. He has also enjoyed teaching Immunology to Clinical Laboratory Science and medical school students at UNC while working in the UNCH clinical labs.  Mr. Hudspeth is an Eagle Scout with 5 palms and has served numerous volunteer positions within the local Scouts BSA Troop and Pack.

Personal Background:

  • Mr. Hudspeth received his Bachelor’s degree in Clinical Laboratory Sciences from the University of North Carolina at Chapel Hill.
  • “Eagle Scout with Five Palms”
  • Avid golfer with a 14 handicap.

Kelli Cable

Ms. Cable has 35+ years – experience in Office, Management, Human Resources, & Customer Service. As the Director of Administration and Client Services, Ms. Cable joined Cord for Life in December 2006, and has assisted in providing more efficient and effective ways to ease the enrollment process, as well as obtaining and establishing excellent customer care during the enrollment and donation period; for our Storage and Donation customers.

Personal Background:

  • Mrs. Cable is married and has two boys.
  • In 1994, Ms. Cable moved to Orlando from Boulder, Colorado.
  • Has a passion for travel and enjoys watching NFL games, cheering on her favorite team, the Denver Broncos.

Sara Irrgang, M.D

During the last two years of Medical School, Dr. Irrgang was in the United States Navy 1915 Ensign Program and completed a clerkship at the Naval Hospital at Charleston, South Carolina as well as a research clerkship at the Naval Aerospace Institute at Pensacola, Florida. Dr. Irrgang completed her four year Pathology residency at Baylor University Medical Center, and her internship at the University District Hospital, Rio Piedras in San Juan, Puerto Rico.

Currently, Dr. Irrgang is Board Certified in Anatomic and Clinical Pathology and licensed in the states of South Carolina, Texas, New Jersey and Florida and she is an Associate Medical Examiner at the District Nine Medical Examiners Office. Dr. Irrgang is a fellow at numerous organizations including; The College of American Pathologists, National Association of Medical Examiners, Florida Association of Medical Examiners, Seminole County Medical Society, and the Florida Medical Society.

Personal Background:

  • Dr. Irrgang received a Bachelor of Science degree in Pharmacy from the University of South Carolina.
  • Attended the Medical College of South Carolina at Charleston where she earned a Medical Doctorate Degree.
  • Dr. Irrgang has a passion for breeding show horses
  • Dr. Irrgang is a 4-H leader in Lake County, Florida
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