The MHRA Hospital Blood Bank Inspection Process
Arranging a date:
Once your hospital blood bank has been highlighted for inspection an MHRA inspector will ring to arrange a date which will be confirmed in writing. When arranging a date for a routine inspection there will normally be a minimum of two weeks notice. In most instances there will be one inspector unless there is a trainee inspector undergoing tuition. The hospital blood bank inspection will usually be completed in one day. Where possible the following persons are required to meet the inspector:
Ensure all paperwork is in place.
Ensure the lab is clean and tidy
Review the answers given on the compliance form. Where processes, systems etc. have progressed since the completion of the compliance form ensure this information is made available for the inspectors.
Where you know you are not compliant have a prepared project implementation plan. For example if you have no training records in place the plan could include:
|Title||Training Record Implementation|
|Project Objective||Training records for all staff to comply with the Blood Safety and Quality Regulations 2005|
|What is required||Identify the training records which need to be developed linked to all processes undertaken in Blood Bank
Identify who needs to be trained (all staff working at any time in Blood Bank)
Develop the training records
Develop competency assessments
|Project leader||Training Manager (Name)|
Identify who needs training
|Resources required||Time for trainers
Time for trainees
|Constraints||Staff time with shift pattern
Staff working nights and weekends
Only one part-time training officer
Be realistic when identifying the time required to plan and deliver the project.
The inspector arrives
Ensure there is some room the inspector(s) can use with hot and cold drinks available, a table and chair(s) and where there is some peace and quiet to review paperwork.
Introduction of inspection team and laboratory staff
Information gathering, reviewing paperwork
Tentative schedule of how the inspection may be conducted
Overview of the laboratory working practices
Witnessing Tasks being performed
Reviewing Documented Procedures
Asking Questions - Who? What? When? Where?
Investigating Issues - Why?
System Inspection based upon:
Quality management system to include:-
The inspector will also want to review the systems and processes in place for:-
This list is not exhaustive and the inspectors may wish to look at any system/laboratory process.
The laboratory will review the report from the MHRA and respond to the areas where there may be