With the WMDA focus on auditing collection centres this year, the drive to demonstrate governance is never far from the mind, especially when the outcome can be the difference between life and death.
The idea currently under development by the WMDA Quality and Regulation Working Group is to standardise the approach to auditing in order that each registry and donor centre (DC) work to the same criteria. Bone marrow registries and DCs often rely on the services and information held by international partners and suppliers; yet, at present, bone marrow registries and DCs in different countries work to different audit levels and their approach to audits can be vastly different.
Of course, this can be problematic as the data captured by one organisation may comply with the regional or national legal standards and regulations of their government but not of another country. This is a significant problem when you work on a worldwide scale.
A drive towards standardising the audit process will lead to higher quality data and analysis capabilities. Geographical uniformity to processes will streamline the audit process and ensure the information needed is captured first time. This uniform approach will achieve greater efficiencies and compliance as well as analysis of data and outcomes which will lead to global quality improvements within collection centres and DCs.
However, operational change can seem to be an overwhelming task and overhauling your organisations’ audit processes and practices can appear to be a daunting job. For example, putting a robust annual audit lifecycle in place can be taxing and time consuming. Yet, with the right system in place, and the WMDA guidelines, this task can become an altogether less challenging undertaking resulting in real business benefits.
Using an electronic quality management system (eQMS) streamlines and centralises the complete audit lifecycle which, in turn, makes it easier to meet stringent demands of international regulators and accreditors.
In terms of how this will improve the day-to-day running of your collection and apheresis centres, an eQMS with a rigorous audit and non-conformance management capabilities will save valuable time and free up resource by eliminating the need for extensive manual tasks, such as staff chasing up actions and producing extensive reports. Subsequently, this facilitates opportunities for organisational improvements which can then drive higher quality stem cell products and increased donor and recipient safety.
The continuous need to improve donor safety is always at the forefront of bone marrow registries' minds, and with a clear focus on quality this year, the WMDA are driving improvements which will provide great benefits.
To make sure your organisation is ready for the upcoming changes, perhaps it’s now the time to audit your audit processes; is your current quality management system and processes fit for purpose and will they stand up to scrutiny against the new practices and regulations?
Here's how Ideagen works with global bone marrow registries and donor centres, supporting them in their audit management requirements and compliance with regulations such as WMDA, NetCord FACT and JACIE standards.