Blood Traceability

Blood transfusion errors are a significant risk, with potentially fatal consequences. The EU recognised this when it passed the Blood Safety directive, which came into effect in 2005.

The directive was transposed into UK law through the Blood Safety and Quality Regulations 2005. As a result, since November of that year, all UK hospitals and blood banks have been mandated to establish a fully auditable system for the traceability of blood from donor to recipient.

Additionally, records of that traceability from donor to patient must be kept for 30 years. These regulations impact on hospitals in various ways:

1. Traceability: Hospitals must have total traceability of the fate of each unit of blood and retain that information for 30 years.

2. Quality systems: Hospital transfusion laboratories must have a comprehensive quality system in place.

3. Processing activities: Some activities that were conducted by hospital transfusion laboratories are regarded as ‘processing activities’ under the regulations and can only be done by licensed blood establishments.

4. Training, education and communication: The regulations require the provision of training for hospital transfusion laboratory staff.

5. Haemovigilance: The Medicines and Healthcare products Regulatory Agency (MHRA) is chairing a group that is working on serious adverse event/reaction reporting.

Compliance with the regulations is compulsory and monitored by the MHRA. Non-compliance could result in a prison spell for hospital chief executives. Yet many hospitals have not found it easy to meet all their requirements.

Tracking the fate of blood for 30 years is incredibly complex and involves significant time and resources. Funding for such a large scale project may be difficult to secure, especially for smaller hospitals.

And training can be a significant challenge. Many hospitals have a high rate of staff turn-over and use a large number of agency staff. Training all of them can become very expensive.

On the other hand, some larger hospitals, such as the John Radcliffe Hospital in Oxford, have taken the opportunity to completely re-design hospital blood transfusion.

They have incorporated many new technological features, such as barcoded patient identification and bedside handheld computers that help staff through each step of the transfusion processes.

Central to the Oxford project was iSOFT’s iLaboratory TP solution, which controls the movement of stocks around the hospital and interfaces with other applications, such as the Olympus BloodTrack suite.

“iSOFT worked extensively with both the John Radcliffe Hospital and Olympus to develop a comprehensive ‘end to end’ solution that fulfils the requirements of the EU directive,” says George Philp, the company’s portfolio manager, pathology products.

“In addition to this, the interface capability has been extended to provide an ‘electronic self-service’ capability. Patient demographics can be entered at the BloodTrack station and, if the patient qualifies for electronic issue, the system selects the most appropriate blood for use and issues the supporting stationery.

“A prescribing mode [has also been created in which] product specific haematology results are retrieved to assist the doctor in the selection of the most appropriate blood and blood components to request.” iSOFT has now introduced these features as available options for all customers using this interface.

A recent survey carried out by the John Radcliffe found that only 13 NHS trusts in England administer more than 10% of their transfusions using information technology.

Yet systems like the one it pioneered have shown that IT can play a major role in helping hospitals to meet the requirements of the directive and regulations, while tracking information in a more efficient way, saving time and allowing clinicians to focus on the patient.

For more information about iSoft’s iLaboratory solution and blood tracking, contact: Sinead Quinn, Sinead.Quinn@isoftplc.com.