In response to requests for more widespread practical training on heamovigilance compliance within the BSQR, MHRA plan to run QMS education days for HBB and BE to help to provide advice and help, within the regulatory framework, to the whole transfusion community at the MHRA head office at 10SC. The Haemovigilance Team Manager and the Senior Haemovigilance Specialist will run these.

These services will be open to everybody involved with the blood transfusion community, from best practice bodies i.e. SHOT, Quality Managers, laboratory staff, phlebotomists, nurses, clinicians and manufacturers so that the whole transfusion service can benefit from clarification and education centred on the practical application of the BSQR.

The main objectives for the days are to support the protection of public health, maintain safe supply of blood and blood products and try to avoid the need for regulatory action.

The Haemovigilance Team have already run 5 education days 2 with HBB representatives and 3 with manufacturers, of blood transfusion technologies, with a great deal of success so we have decided to, instead of waiting for representatives coming to us, advertise this resource on the MHRA Forum so we can be more proactive with our help. The team can cover most aspects of QMS management and development but to make best use of the time available it is advised that those who are interested identify specific issues that they may have issues with such as change control, validation, temperature monitoring/mapping and capacity planning. Additionally, it is also advised that sites from within a region/trust arrange convenient dates so personnel can attend together so best use of this initiative can be achieved.

While practical advice will be provided and scenarios discussed, MHRA cannot, for reasons of conflicts of interest, adopt a consultancy role and fix issues for you.

These QMS education days do not replace the Haemovigilance Teams site visits to laboratories and transfusion committee meetings, it is hoped that, on request, these will continue within the limited resources that we have.

Education days, however, will not be available to sites that are under the MHRA Compliance Management Team (CMT) because of legal reasons.

Numbers are limited to a maximum of 8 individuals at any one time due to available office space at 10SC and we will need at least 4 weeks’ notice so adequate office space can be booked with dates being agreed between the requestor and the Haemovigilance Team. Representatives T&S costs will have to be covered by your own trusts as the haemovigilance budget is limited.

Please make your requests through the Haemovigilance Team by E Mailing us via the addresses below:

Kind regards

The Haemovigilance Team