Hi MJWL

Your query relates to the safe and secure storage of blood and blood components. Within the Good Practice Guide there are many paragraphs related to the general principles for storage but the most relevant to your query is within section 3.5 Storage Area.

3.5.1. Storage areas must provide for appropriately secure and segregated storage of different categories of blood and blood components and materials, including quarantine and released materials as well as units of blood or blood components collected under special criteria (e.g. autologous donation). Access must be restricted to authorised persons (Directive/2005/62/EC/Annex 3.3.5.1).

Applied to your query “Access must be restricted to authorised persons” which means there must be no access to stored blood and components by any untrained or unauthorised person. The Access without ID function can be removed or hidden. However, this does not mean that any “log in without ID function” should be removed for emergency and urgent situations as described in a site’s policy, but that the requirement must be controlled by the quality system as a whole. i.e There must be clear policies and procedures, including training that covers storage. There must be provision in place to ensure that there is appropriately trained staff available or to alert the BMS in the lab when emergency blood is required.

Any single breach which involves untrained and unauthorised access to blood and blood components should be reported to the Competent Authority i.e MHRA via SABRE.

I hope this helps