Hospital Circular 16/2008
Date Issued: 18 June 2008
Distribution: All public hospitals providing maternity services
Subject: Autologous Private Cord Blood Collection in Public Hospitals
Purpose: To advise all public hospitals providing maternity services of the Victorian policy regarding the collection of umbilical cord blood (in public hospitals) by private cord blood banks
Background
Cord blood is collected from the umbilical cord after the birth of a baby once the
umbilical cord is cut. The cord blood is rich in blood stem cells that are normally found in the bone marrow.
Currently, in Victoria, cord blood can be donated in three ways:
- As a non-directed donation to the not-for-profit public cord blood bank managed by the Bone Marrow Donor Institute Cord Blood Bank at the Royal Children’s’ Hospital. In Victoria, specially trained staff collect cord blood at The Royal Women’s Hospital, Box Hill Hospital and Angliss Hospital. This cord blood is an altruistic donation and is made available for transplantation to any appropriate patient in Australia.
- As a directed donation to a family member with a proven sickness needing a stem cell transplant; and
- As an autologous, private donation for future personal use. This service is only offered by private cord blood banks.
An independent review of the national public cord blood bank network which is funded by all Australian Governments was undertaken in 2006. The review noted that the role of cord blood gene therapy and the use of cord stem cells in a wide range of clinical areas is likely to be a major focus of research over the next ten years. However the review also advised that beyond the next five years, it was likely that newer targeted therapies for haematological cancers would result in a decrease in indications for cord blood transplantation. On the basis of the report, Governments confirmed that Australia's public inventory of cord blood units is already sufficient, and that future cord blood collection activity be directed towards maintaining the inventory and increasing its genetic diversity.
Autologous private cord blood banking
A number of private cord blood banks have now been established in Australia. These banks provide a service whereby mothers may have their newborn baby’s cord blood removed and stored indefinitely for the purpose of private potential future use by the baby or a family member. Private cord blood banks charge an initial collection fee and an annual storage fee.
According to the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) College Statement of July 2007, (Number. C- Obs 18):
This is a rapidly progressive area of clinical medicine. It is possible that future advances may attach considerable value to these cells, in the event of childhood or adult-onset disease in the individual from whom the stem cells were obtained.
On the other hand, it is also possible that parallel advances in genetic manipulation of donor stem cells may render the expense of a directed donation unnecessary.
If a donor developed a haematological malignancy and required a transplant in the future their own stored cord blood is generally not recommended to treat their subsequent malignancy. The use of that cord blood for an HLA-compatible relative is theoretically acceptable if permitted in the contract with the private facility storing the stem cells.
At this stage, each individual should make a decision, weighing the considerable cost of directed donation against an uncertain probability of future benefit.
Some practical implications of autologous private cord blood collection
Autologous cord blood collection for private storage does impose some clinical burden including:
- Interference in the management of the third stage to allow cord blood collection at a time when the mother is at risk of postpartum haemorrhage.
- Pressure to collect a sufficiently large volume of cord blood, as there is a minimum volume of cord blood requirement.
- The requirement for adequate aseptic technique.
- Completion of additional associated paperwork.
Victorian policy for autologous private cord blood banking in public hospitals providing maternity services
All Victorian public hospitals providing maternity services must develop their own policy on whether or not to allow autologous private cord blood collection through commercial providers.
If a Victorian public hospital chooses to allow autologous private cord blood banking then that hospital must develop and implement a written policy, including appropriate protocols governing the conduct of private cord blood banking procedures on hospital premises. It is expected that, at a minimum, the policy will incorporate the following matters:
- Publicly funded facilities and staff resources are not to be used for the collection, transport or storage of cord blood for private cord blood banks.
Hospital/patient/private cord blood bank information exchange
- Mothers must be made aware, in writing, that private cord blood banking is not provided as a service by the hospital and that the hospital, and its staff, has no responsibility for and no involvement with, the private cord blood bank or its activities.
Mothers must inform the hospital prior to admission that they have an arrangement with a private cord blood bank. - The private cord blood bank must provide current documented protocols and procedures to the hospital, to all relevant hospital staff and to the patient.
- All visitors to the hospital involved in private cord blood collection must explain all relevant processes and interventions to the appropriate manager/delegate prior to collection.
- Mothers must be made aware, in writing, that private cord blood banking is not provided as a service by the hospital and that the hospital, and its staff, has no responsibility for and no involvement with, the private cord blood bank or its activities.
Quality and safety standards
- The hospital must be satisfied that:
- any member of staff of the private cord blood bank carrying out the cord blood collection at the hospital is appropriately qualified and experienced.
- the private cord blood bank holds adequate and current public liability insurance and professional indemnity insurance
- The collection of cord blood must not interfere with the delivery of the baby or placenta or any emergency procedure required.
- All visitors to the hospital involved in private cord blood collection must satisfy the public hospital’s requirements for identification at all times.
- All visitors to the hospital involved in private cord blood collection must abide by any necessary directions given by management/delegate as appropriate (e.g. emergency procedures, security responses).
- A risk management plan must be developed by the private cord blood bank to respond to any unintended event occurring during the collection process and a copy of that plan must be provided to the hospital.
- Protocols must be established to ensure that an appropriate entry is made to the patient record to indicate that cord blood was taken by a private cord blood bank.
Dr C W BROOK Lance Wallace
Executive Director Executive Director
Rural and Regional Health & Aged Care Services Metropolitan Health & Aged Care Services
