The BMDI Cord Blood Bank (CBB) is a state and federal government funded public CBB that is managed by a tripartite consortium comprising representatives from the Bone Marrow Donor Institute (BMDI), the Royal Children’s Hospital and the Murdoch Children’s Research Institute.
The CBB collects umbilical cord blood that contains haemopoietic (‘blood cell forming’) stem cells from four Melbourne metropolitan maternity hospitals from consented donors. This is used to manufacture cord blood units (CBU) that can be used as an alternate treatment for both adult and paediatric patients requiring a bone marrow transplant, especially those that are unable to be matched with a suitable bone marrow donor.
Q-Pulse, the compliance management solution developed by Gael Ltd, was chosen to help the BMDI CBB efficiently and effectively manage their quality management system (QMS) processes. Health Care Informed (HCI) is part of Gael’s global business partner network and is an approved provider of Q-Pulse in the healthcare sector.
The Challenge
The BMDI Cord Blood Bank's processing, storage and office facility is located at The Royal Children’s Hospital, Parkville, Victoria. Regulated by the Therapeutic Goods Administration (TGA) of Australia, it’s licensed to manufacture and release CBU only for allogeneic use.
Dr Jennifer Cauchi, Quality Manager at the BMDI CBB, said: “Our collection, processing and storage facilities are regularly inspected and accredited by two regulatory bodies locally by the TGA, and on an international level, the Foundation for the Accreditation of Cellular Therapies (Netcord-FACT).
“To maintain its TGA license and FACT accreditation, and to meet the stringent safety and quality standards required, we have to have a rigorous, continuouslyimproving, formal quality system in place.
“Having to manage and track our compliance activities such as document control, auditing and suppliers meant that the BDMI CBB required an integrated QMS to do this successfully and meet our regulatory requirements.”
The Solution
Q-Pulse helped the BMDI CBB organisation efficiently and effectively manage all their QMS processes and procedures, whilst enabling them to achieve and maintain compliance with their regulatory requirements and quality standards.
Dr Cauchi added: “In managing our quality system, Q-Pulse gives us very easy-to-use, comprehensive support, especially in control of our documentation from both internal and external sources, management of critical equipment, materials and approved suppliers, management of audits and non-conformance incidents.
“We worked with HCI to extensively review and improve our quality and safety processes. In particular the responsibilities of senior staff members had to be assessed in managing their areas of the quality system. This allowed us to really look at how we do things, identify areas where we could improve, customize the software to our unique situation, redistribute the workload and become more efficient. We then implemented Q-Pulse to match these improvements after migrating our historical information, so we could implement an integrated system that would be applicable to all areas.”
The Result
Q-Pulse has helped change the management of internal processes within the BDMI CBB, becoming the user friendly system that helped ensure the cord blood bank met their regulatory requirements and improved their services.
Dr Cauchi added: “Most staff now have controlled access with ‘easy-to-find’ information, and as a result we’ve found it much easier to maintain and improve our management system processes, especially facilitating improved management of our audit schedule, identifying opportunities for improvement, and ensuring our approved supplier list is up-to-date.
“We primarily use Q-Pulse to ensure strict document control, as it is through our detailed documentation that we can readily demonstrate and ensure compliance of staff with regulations. As it automatically reminds staff when documents need to be updated, readily details change requests, as well as emailing relevant users with new protocols, we can be sure all staff are aware of new or revised policies, procedures and forms. The revised processes clearly demonstrate the approval levels for documents, which has made it far easier for staff. As a Quality Manger, I also really appreciate the full audit tracking and traceability within the system."
Jennifer concluded: “Putting Q-Pulse into place has changed the way we work considerably within the CBB by providing us with a very user-friendly system that will ensure we can continue to meet our regulatory requirements and improve our services. Having all the information stored centrally allows easier and more efficient access for staff, management, and enables us to demonstrate our quality control mechanisms to external regulators.”