Download L i f e b a n k

page 1
Lifebank
Cord Blood Stem Cell Bank
Information Pack age
Lifebank
I n fo r m at i o n P a c k a g e
W e l c o m e To L i fe b a n k
page 1
Together we can
make a difference...
We believe the miraculous
potential to save a life lies in
umbilical cord blood stem cell
storage and scientific discovery.
This motivates Lifebank each and
everyday to do our best for you
and your family.
Since 1996, Lifebank has been
providing an option for your family
that may aid in the treatment of
a disease or injury.
Your decision. Your family cord
b l o o d b a n k . Lifebank
I n fo r m at i o n P a c k a g e
3 S te p P ro c e ss
page 2
The process for collection and storage of Cord Blood is simple, non-invasive and takes just a few minutes.
1. Registration:
Complete our simple secure online registration with
"digital signature", or download our registration forms
and return them to us by fax or mail. Upon receipt of
your completed forms, a Lifebank representative will
contact you and arrange delivery of your collection kit.
The kit contains everything your healthcare professional
needs to safely collect your baby’s cord blood for storage.
2. Collection
Bring your collection kit to the hospital and your cord
blood collection is performed by your healthcare
professional , which takes only a few minutes. Step-bystep instructions for cord blood collection are included
with your kit. As required by regulatory agencies,
a small sample of mother’s blood will also be taken to
test for infectious diseases.
Storage Chambers
Cord blood is stored in cryogenic storage
chambers following strict regulatory requirments
Testing for Diseases
A sample of the mother’s blood is taken at the time cord blood
is collected from the baby. Utilizing Health Canada and FDA
approved donor screening for all test procedures, the mother’s
blood is then tested for:
* anti-HIV 1 / 2 (antibody - Human
Immunodeficiency Virus Type 1
and 2)
* NAT HIV (Nucleic Assay
for detection of Human
Immunodeficiency Virus Type 1)
* anti-HTLV I / II (antibody - Human
T - Lymphotropic Virus I / II)
* HBsAg (Hepatitis B surface
antigen)
* anti-HBc (antibody - Hepatitis B
core)
* anti-HCV (antibody - Hepatitis C
virus)
* NAT HCV (Nucleic Assay for
detection of Hepatitis C virus)
* Syphilis (detection of Treponema
Pallidum antibodies)
* CMV (Cytomegalovirus)
* NAT West Nile (Nucleic Assay for
detection of West Nile virus)
* T. cruzi (Trypanosoma cruzi)
A positive infectious disease test result (excluding CMV) may
preclude you from storing your baby’s cord blood unit.
3. Storage
Cord blood is immediately sent to
Lifebank’s accredited cryopreservation
laboratory for processing and onsite storage. Processing is performed
within 48 hours of birth. Cells are
stored cryogenically, available for immediate
use by your family.
Lifebank
I n fo r m at i o n P a c k a g e
C o rd B l o o d Q & A
page 3
1. Why store your baby’s cord blood?
The umbilical cord blood of a newborn contains a high concentration of stem cells – the building blocks of both
the blood and immune systems. These cells are one of the most powerful and miraculous cells known to science.
Saving your baby’s stem cells may provide medical treatment of a disease or injury in the future.
2. Why is it so important for my baby to have his or her own stem cells for future use?
Because your baby’s own umbilical cord stem cells are perfectly matched to his or her immune system there is no
chance of rejection whatsoever. Using stem cells from a donor umbilical cord would require a near-perfect tissue
match, which is often difficult and sometimes impossible to find.
3. When is my baby’s cord blood collected?
Cord blood is collected immediately after the safe delivery of your baby, with the umbilical cord clamped and cut
and your baby is safely in your arms or the obstetric team’s care. It is a simple, non invasive procedure that only
takes a few minutes.
4. What if my healthcare professional is not familiar with cord blood collection?
a detailed written, pictorial, and video collection guide is available for your healthcare professional. The collection
process is safe and simple to perform, taking minutes to complete. If further details are required, our Lifebank
staff of professionals are available to discuss the procedure with your healthcare professional.
5. If the delivery is by C-section, does that affect the collection?
Due to Lifebank’s utilization of a validated sterile collection bag (the first cord blood bank in Canada to
implement this system), healthcare professionals may collect the cord blood following a C-section procedure
with no risk to mother or baby. all Lifebank collection kits include this sterilized system for use during C-Sections.
Numerous studies comparing vaginal vs. cesarean delivery show sample volumes are virtually the same.
6. How many years has Lifebank been in operation?
Lifebank was the first family cord blood bank in Canada and has been in continuous operation since February of
1996. We have over 15,000 units in storage and have successfully provided our families with needed cord blood
stem cells for medical treatments.
7. Is the facility Health Canada and FDA registered?
Lifebank is Health Canada and FDa registered.
8. Is the storage facility FACT and AABB accredited?
Lifebank is the first family cord blood bank in Canada to be FaCT (2010) and aaBB (2003) accredited.
9. Does the facility operate exclusively as an experienced processing and storage facility for
umbilical cord stem cells?
Since 1996, we have exclusively dedicated our expertise to the processing and storage of cord blood stem cells.
Lifebank
I n fo r m at i o n P a c k a g e
C o rd B l o o d Q & A
page 4
10.Is the facility's Medical Director a physician with a required regulatory credentials and experience ?
Lifebank’s Medical Director is Dr. Anil Mangal. Dr. Mangal is a fellow of the Royal College of Physicians of Canada in
Hematology (FRCPC). He did all his post-graduate training including residency and Fellowship with the University of
British Columbia at the Vancouver General Hospital. He also holds Board Certification in American Board of Internal
Medicine (ABIM) and a Masters of Business Administration (MBA) from Simon Fraser University. Dr. Mangal is also currently
Clinical Assistant Professor in the Department of Pathology & Laboratory Medicine at the University of British Columbia
Faculty of Medicine and a Hematopathologist with Lifelabs Laboratories in clinical hematology practice. Previously, he
was Medical Director of Canadian Blood Services (BC & Yukon Centre), from 1997 – 2001, and has held senior
hematopathology positions since 1983 in both the private and public health care sectors.
the cord blood stem cell lab and bank located in the same facility?
11. Is
At Lifebank, processing and storage is performed on-site at our secured state-of-the-art laboratory facility. We
do not sub-contract out any of our storage to a tertiary company.
12. A re facility personnel available 7 days a week to assist with transportation of the cord blood
unit to the facility?
Lifebank personnel are available 7 days a week to directly assist with the transportation of collected cord blood
units. The Lifebank collection kit provides the protection necessary for the safe and secure return of the cord
blood unit to our facility.
13.Will you have direct access to your baby’s cord blood stem cell unit?
Lifebank is a family cord blood bank, which means you will always retain ownership of your baby’s cord blood
unit.
Lifebank
I n fo r m at i o n P a c k a g e
A c c re d i t at i o n s
page 5
Upholding the highest clinical standards, and reaching to new levels of customer care and best practices, Lifebank is proud to be
officially accredited by the organizations below. We are the only FACT accredited cord blood stem cell bank in Canada.
foundation foR the accReditation of ceLLuLaR theRapy
FaCT accredits facilities under the two sets of international standards developed in
cooperation with JaCIe and NetCord:
FaCT-JaCIe International Standards for Cellular Therapy product Collection,
processing and administration. These Standards apply to hematopoietic
progenitor cells isolated from bone marrow or peripheral blood and to all phases of
collection, processing, and administration of these cells.
NetCord-FaCT International Standards for Cord Blood Collection, processing, Testing,
Banking, Selection and Release. These Standards apply to facilities and individuals
performing cord blood collection, processing, testing, banking, selection and release of cord blood units.
These standards were developed by international teams of experts in the field of cellular therapy and cord blood banking. The
standards contain the minimum guidelines for facilities and individuals performing cellular therapy product transplantation,
cord blood banking, or providing support services for such activities.
accreditation is awarded after successful documentation of compliance with the current standards. Compliance is determined
by evaluation of written documents provided by the facility and by on-site inspection. On-site inspections are carried out by
a team of inspectors who are qualified by training and experience, have attended inspector training and who have a working
knowledge of FaCT-JaCIe Cellular Therapy product Standards or NetCord-FaCT Cord Blood Banking Standards, as appropriate,
and of their application to various aspects of the facilities being inspected. The inspection process is quality-oriented and
follows the FDa’s rules for current good Tissue practice (cgTp).
American Association of Blood Banks
The AABB Accreditation program promotes the highest standards of care
for both patients and donors in all aspects of blood banking, transfusion
medicine, relationship testing, hematopoietic, cord blood and other
cellular therapies. In June 1995 and again in May of 2008, AABB was
granted “deemed status” as an accrediting organization under the Clinical Laboratory Improvement Amendments of 1988
(CLIA). Most recently, the accreditation program was accredited by the International Society for Quality in Healthcare (ISQua).
Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP) regulations, CLIA ’88 requirements, increased
regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality
Management systems, competition within the blood banking profession, advances in the cellular therapy arena, and
increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy
communities conduct business. Conducting business in a quality framework is no longer an option, but a must. Ensuring that
all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any
successful operation.
The goal of accreditation is to verify compliance with applicable AABB Standards and federal regulatory requirements and to
assist in improving the quality of services provided. Verification of compliance is accomplished by peer review assessments
performed in a competent and reliable manner.
Compliance and Education
The assessment provides a review of a facility’s compliance with AABB Standards. This includes an audit of the quality and
operational systems. The experience and expertise of the AABB assessors also makes the assessment process an educational
experience.
Lifebank
I n fo r m at i o n P a c k a g e
R e g is t r at i o n I n fo
page 6
Basic Steps to Register with Lifebank
Step 1: Read and sign the Informed Consent documents.
Step 2: Read and sign the “Client Service Agreement”.
Step 3: Fill in the “Client Health Questionnaire” to help Lifebank determine the suitability of
your child’s cord blood sample.
Step 4: Complete the the “Physical Assessment Letter” (to be signed by your physician).
Step 5: Submit the completed forms. This process varies depending on the registration method.
Important message:
In compliance with government regulations, Lifebank will not accept clients for family
cord blood stem cell banking with known blood transmissible diseases (HIV, HTLV and
Hepatitis B and C). If you have any questions or concerns regarding this matter, please
call to discuss with a Lifebank Customer Representative at 604-738-2722 or toll free
1-888-888-7836. Thank you.
Before you start
Download and print the “ Physical Assessment Letter” — This document must be
completed and signed by your physician to complete the registration process.
Registration Options:
We are always happy to answer any question you may have at 1-888-888-7836.
Lifebank
I n fo r m at i o n P a c k a g e
C o n t a c t I n fo
page 7
HEAD OFFICE & LABORATORY FACILITY
Technology Place - BCIT Campus
Suite 200 – 4475 Wayburne Drive
Burnaby, BC V5G 4X4 Canada
Phone: (604) 738-2722
Toll Free: 1-888-888-7836
Fax: (604) 738-2726
Toll Free: 1-888-544-2726
Email: [email protected]
Lifebank’s Head Office and Laboratory Facility.
IP001 2012.02.22