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The following questions are based on a list of suggested questions found on a web site called "A Parent's Guide to Cord Blood Banks", used with the kind permission of the site's creator, Dr. Frances Verter. This site is an excellent independent resource for parents considering cord blood banking.
We've provided complete answers to each question below. If you have further questions, please feel free to contact us.
1. Collection of Cord Blood Sample
2. Shipping & Handling
3. Laboratory Testing & Accreditation
4. Processing
5. Storage Facility
6. Company Stability
7. Consumer Rights
8. Price protection
1. Collection of Cord Blood Sample
Will the company proactively contact the labor and delivery staff for you (or are parents responsible for keeping them informed and coordinated)?
We ask that our clients make sure that, prior to delivery, their caregiver has been notified of their plans to preserve their cord blood, and familiarized themselves with our kit and thorough collection instructions. If the caregiver has any questions one of our knowlegeable staff are always available and willing to help.
Do they collect cord blood before or after delivery of the placenta?
The Genesis Bank leaves this decision to the caregiver. Our directions for collection assume that it will take place within 15 minutes after delivery of the placenta. If the caregiver prefers to collect prior to delivery of the placenta, our kit is perfectly suitable. Both methods are routinely used with comparable volumes collected.
What collection method do they use?
The Genesis Bank prefers the gravity feed method, using the provided blood collection bag, for several reasons:
(1) The provided blood bag contains an anticoagulant along with special media to help extend viability during the transfer from the hospital to our lab. The syringe method usually employs Heparin anticoagulant only, which does not contain this media.
The syringe method may be used, but we do not provide syringes in the cord blood collection kit. Of course, hospitals and/or delivery centers should have syringes readily available.
(2) Syringes can present problems during shipping if they are not capped and taped appropriately (leakage can occur). Clamps are provided with the kit for the bag's tubing which is also tied off to ensure no leakage can occur.
(3) Finally, there is less chance of contamination using the bag method. If the kit for any reason cannot be used, we do accept and process blood collected using the syringe method.
What storage container do they use, vials or a bag?
The Genesis Bank stores all cord blood specimens in the bag attached to the closed system transfer set. A 2 mL vial is also filled with a small amount of blood for any potential testing that may be required including HLA typing if the unit is to be used for someone other than the donor.
What equipment is provided in the kit for the physician, and are there any spares?
All of the equipment necessary for collection and shipment of the blood is included in the cord blood collection kit along with collection instructions. The Genesis Bank kit is contained in a box which is reused for shipment back to the lab. The box contains the sterile cord blood collection bag and a large resealable clear plastic bag containing an absorbent towel, 2 antiseptic towlettes and two cord clamps; and a small resealable clear plastic bag containing an alcohol prep pad, antiseptic towlette, a non-latex tourniquet, a blood draw needle, a vacuette tube holder, one purple- and one red-top vacuette tube. The box also contains packaging materials and instructions to ship the kit via FedEx or medical courier. A check-list accompanies the collection kit. We ask that the parent(s) inspect the kit using the check list to ensure everything was included and is in satisfactory condition. If for some reason anything is defective or missing, The Genesis Bank will immediately send any supplies that you might need for collection.
What instruction tools are provided for the physician?
Detailed instructions for the caregiver including schematic drawings are provided in the collection kit.
2. Shipping & Handling
Is shipping included in the contract?
Airbills for either FedEx or AirNet medical courier service are provided in the cord blood collection kit along with shipping instructions. If you are shipping with FedEx there are no additional shipping charges. However, if you are shipping with same day AirNet Express, there is an added fee of $200.
If the bank uses a courier, do they provide secure chain-of-custody handling?
AirNet Express provides chain-of-custody handling.
On weekends, are the laboratory staff in-house or on-call?
Trained laboratory staff are in-house on Saturdays. On Sundays, there are always at least two on-call staff members available.
3. Laboratory Testing & Accreditation
Will they notify the parents of the time at which the cord blood arrived, and the time at which it was processed?
The date and times at which blood arrives and is processed are documented and reported to the parents. Clients receive a certificate of storage that presents all of this information as well as test results, cell counts, viability results and (if requested) colony formation results*.
*The colony formation assay (CFU assay) is an additional $250.00
What tests are performed on maternal blood?
Do they ever reject samples on the basis of maternal tests?
We do not reject samples on the basis of maternal tests. If a maternal sample is positive, the sample is stored in special quarantine areas.
Do they test the cord blood sample for infectious disease markers?
Cord blood is not tested for infectious diseases. Since most tests rely on antibodies, they would not be effective on cord blood. This is due to the fact that a new born's immune system has not yet had a chance to develop these antibodies. Cord blood type is also tested and reported on the certificate of storage.
What other contamination tests are performed on the cord blood sample?
The cord blood itself is tested for bacterial and fungal contamination.
Do they ever reject samples that are contaminated?
Samples positive for contamination are not rejected, but they will be stored in our quarantine areas. The client will be notified if contamination is detected and will be given the option to keep the unit or discard it.
Will they notify parents of the test results?
Parents are notified of all test results.
Do they maintain a separate "quarantine tank" for the long-term storage of blood that has failed one or more tests, or is the blood stored together regardless of testing status?
At this time, a storage column within a Nitrogen vapor tank is used as the quarantine area for infected or contaminated samples. Because only vapor tanks are used, and there is no mixture of "clean" and "contaminated" sample vials or bags within boxes or columns, this is an appropriate quarantine procedure.
Do they HLA type the sample?
HLA typing is not routinely performed or included in the standard pricing, but can and will be done if requested. This involves an additional cost of $600. HLA typing can be performed at the time of processing or any time after by thawing the 2ml test cryovial.
By which organizations are they accredited?
The Genesis Bank is a licensed by the Indiana State Department of Health as a Blood Center. The Genesis Bank is also registered with the FDA as a Human Cell and Tissue Based Products institution (HCT/Ps). of Health. We are also a member of the Better Business Bureau and are in the process of achieving our AABB accreditation.
Some states license cord blood banks (NJ, NY): Do they operate in those states?
We are proud to announce that The Genesis Bank is now licensed by the States of New York and New Jersey, which have the most stringent regulations of all states requiring licensing for processing and storing cord blood stem cells.
4. Processing
Is the blood stored whole or processed to separate mononuclear cells (MNC)?
The Genesis Bank processes the blood to separate the mononuclear cells. Unlike most cord blood banks, The Genesis Bank gives its clients the option of using the Ficoll-Hypaque method or the more standard Hespan (hetastarch) volume reduction method conducted by most public and private cord blood banks (an additional charge of $100 will be added if the Ficoll method is chosen due to the extra time and cost associated). The Genesis Bank prefers the standard Hespan method, because this allows the entire process to be performed in a "closed" system (a sterile blood bag transfer set), greatly reducing the chances of external contamination while processing. The Ficoll method is typically performed in an "open" system (screw-top centrifuge tubes) and involves much more manipulation.
What is the minimum volume they will accept for storage?
There is no minimum volume at The Genesis Bank. We do our best to preserve the volume collected and sent to us, although with low volumes (under 50 ml) we will contact the client to see if they are still interested in preserving it or not. While an argument exists that storing smaller samples will not meet the required dose for transplant, technology is developing to expand the cells and/or increase the actual percentage of cells that will engraft. As this technology continues to grow, the initial volume collected will likely become less important.
Is the blood stored as a single unit or several samples?
We store in bags (one 30 ml compartmented bag). A small aliquot is saved for potential future testing (e.g. HLA typing or CFU assay).
5. Storage Facility
Do they operate their own storage facility or lease space in one? AND In what type of facility is the bank located?
The Genesis Bank operates its own storage facility in the Harlan Biotechnology Center (HBC) immediately adjacent to the Indiana University School of Medicine and Clarian Health Hospital network. The Genesis Bank leases space in the HBC, which is owned by one of The Genesis Bank's parent company (General BioTechnology, LLC) partners.
The Genesis Bank's facility has diesel back up generators and all storage tanks are 24-hour alarm monitored by a 21 CFR compliant temperature monitoring system interfaced with the building central security system.
The Genesis Bank operates its own cord blood processing laboratory and storage facility separate from any of the research conducted by General BioTechnology, LLC.
What is the geographic location of the storage facility?
The Genesis Bank is located in Indianapolis, IN, the midwestern part of the United States. Our processing laboratory, storage facility and offices are located in the same building.
Are the cord blood samples in a separate freezer or mixed with other medical samples?
The Genesis Bank maintains separate Nitrogen vapor storage dewars specifically for its clients. These vessels store cord blood for clinical use ONLY. There are no research and/or other samples stored in these vessels.
What type of freezer do they use?
The Genesis Bank stores cord blood samples in large vacuum walled containers (dewars) which are kept cold by liquid Nitrogen. The samples themselves are stored in Nitrogen vapor at a constant temperature of -190*C. There is no machinery (e.g. condensers) or mechanical parts in our storage freezers, so they do not require outside power to work. Additionally, the tanks can maintain their temperatures for over 2 weeks without the addition of liquid Nitrogen. All of our storage tanks are alarm monitored 24 hours a day using a 21 CFR compliant temperature logging system tied into the building's central security system. This system measures the temperature in the very top of the freezer (the "warmest" part of the container) and constantly logs a record of the temperature history. If at anytime the temperature gets above -130*C, the system goes into alarm, activating a local siren and notifying the central monitoring company. The monitoring company then calls Genesis Bank staff directly who would remedy any problem.
Do they freeze in liquid nitrogen or vapor nitrogen?
As mentioned above The Genesis Bank freezes our samples in vapor nitrogen.
What type of records do parents receive after storage?
All of our clients will receive a certificate of storage that presents all of the test results (viral screen, sterility, viability, total nucleated cell count, blood type, CD34+ count), birth date and location.
Does the contract state that the storage fee is fixed, or may it increase later?
The storage fee is fixed if the client decides to purchase a long term storage contract. With storage paid on an annual basis there is a chance that the costs could increase.
Does the bank reserve the right, in the contract, to change storage facilities?
The Genesis Bank does reserve the right to change its facility, however, if this were to occur all samples would be transferred appropriately and maintained in the same rigorous manner.
6. Company Stability
Is the company public or private?
The Genesis Bank is a private company.
Is the company affiliated with a hospital or research institution?
The Genesis Bank is affiliated with General BioTechnology LLC, which is a leading research and development and cell processing company.
Is the company involved in bio-technology research and development?
Yes.
What other medical services does the company perform?
The Genesis Bank is only in the business of processing and storing cord blood. Its parent company, General BioTechnology, is continually conducting research to improve these processes and the potential of the stem cells derived from the cord blood and other "adult" sources.
How long has the company been banking cord blood?
The Genesis Bank has been banking cord blood as a clinical blood center since July of 2004. The Genesis Bank's parent company, General BioTechnology LLC, has been developing improved cryopreservation and storage of umbilical cord blood stem cells since October of 1997.
Who directs the day-to-day business of the company?
Day-to-day business operations are directed by Erik Woods, Ph.D. the Founder, CEO and Laboratory Director, and Michael Byers, M.B.A. the Vice President of Operations and Technical Supervisor. Both Dr. Woods and Mr. Byers are on site full time and are available to answer any questions a client may have. We also have a rotating staff of three medical directors to ensure at least one physician is available at all times. Our medical staff consists of: Mervin C. Yoder, Jr., M.D., Richard and Pauline Klingler Professor: Department of Pediatrics, Biochemistry and Molecular Biology, Herman B Wells Center for Pediatric Research, Indiana University School of Medicine (Clinical Section: Neonatal-Perinatal Medicine); David A. Ingram Jr., M.D., Assistant Professor: Department of Pediatrics, Biochemistry and Molecular Biology Herman B Wells Center for Pediatric Research, Indiana University School of Medicine (Clinical Section: Neonatal-Perinatal Medicine); and W. Scott Goebel, M.D., Ph.D., Assistant Professor: Department of Pediatrics, Herman B Wells Center for Pediatric Research, Indiana University School of Medicine (Clinical Section: Pediatric Hematology/Oncology and Pediatric Stem Cell Transplantation Program).
How many privately banked cord blood samples do they hold?
Currently The Genesis Bank has banked over 4,000 cord blood samples.
How many transplants have been performed with their cord blood samples?
Presently, no Genesis Bank clients have used their stored blood for transplants. Using the colony formation assay (CFU assay), adequate colony formation has been observed in all of our thawed and tested units. Additionally, one of our Medical Directors, Dr. Goebel, has personally performed over 40 cord blood transplants utilizing blood from public banks.
7. Consumer Rights
If the cord blood is lost or severely delayed during shipping, what liability does the company accept?
The Genesis Bank can not be held liable for any problems that may arise due to shipping, this is something that must be taken up with FedEx or AirNet Express. If a sample has been delayed or damaged in shipping and is no longer viable for processing, The Genesis Bank will not charge the $975 processing fee (the initial deposit of $175 for registration and the cord blood collection kit is not refundable).
If the storage fee is not paid, what happens to the cord blood?
In The Genesis Bank service agreement (contract) it states that if a client does not pay the storage fee The Genesis Bank may give 30 days notice to terminate the contract and request transfer or disposal instructions. If no instructions are given, after 90 days the cord blood can be donated to a public bank, donated for research use, or discarded.
Does the company take ANY portion of the cord blood for proprietary purposes, or does 100% go into storage?
100% of the cord blood goes into storage.
Does the contract protect the privacy of the parents' health information, as stipulated by The Health Insurance Portability & Accountability Act (HIPAA regulations)?
Yes, The Genesis Bank will not release any of your information - health or financial - to any outside or third party.
8. Price protection
Is the enrollment fee charged once per family, or for each birth?
The Genesis Bank enrollment fee only covers the cost of the cord blood collection kit and the shipping of the kit, therefore it applies for each birth, not just once per family.
At what week of gestation are late enrollment fees imposed, and how much are they?
The Genesis Bank does not charge any late enrollment fees and will work with your caregiver and/or hospital to collect the cord blood if there is not enough time to get a cord blood collection kit sent out and received.
How do they charge for cord blood samples from multiple births?
As mentioned above, due to the extremely competitive price that The Genesis Bank already offers, we do not currently offer any discounts for multiple births.
If the cord blood collection is small or contaminated, are parents offered any refunds?
Yes. The entire $975 processing fee is completely refundable if the blood is contaminated or the amount collected is too small (the $175 deposit and registration fee is non-refundable).
Is the storage fee guaranteed fixed?
The storage fee is fixed if the client decides to purchase a long term storage contract. With annual storage there is a chance that the yearly storage costs could increase. Any increase would only be due to a rise in our costs and adequate notice would be given prior to any change.
Updated 6/12/2007
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