JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

MHRA Inspection Process

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:

MUST

  • Blood Bank Manager
  • Consultant Haematologist
  • Quality Manager

COULD

  • General Pathology Manager
  • Transfusion practitioner
  • Senior members of staff
  • Estates staff if fridges are serviced internally
  • Laboratory IT Manager

Hospital Preparation
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)
Time scale

Identify who needs training
To develop training records
Develop competency assessment
Deliver training



2 weeks
2 months
2 months
9 months
Resources required Time for trainers
Time for trainees
Printing/stationery
Exclusions None
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.

Opening meeting
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

The Inspection
Obtaining Information
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:-

  • Personnel
  • Premises and Equipment
  • Documentation
  • Complaints/component recall
  • Self Inspection
  • Training records
  • Validation and calibration documents

The inspector will also want to review the systems and processes in place for:-

  • Traceability
  • Storage and distribution
  • Review of Serious Adverse event/reaction reporting
  • Crossmatching / automation

This list is not exhaustive and the inspectors may wish to look at any system/laboratory process.

Closing meeting

  • Closing meeting by inspector
  • Presentation of findings
  • Opportunity for establishment to provide further information
  • Acceptance of findings
  • Notification of next steps

Post Inspection
The laboratory will review the report from the MHRA and respond to the areas where there may be

  • Critical
  • Major
  • Significant other deficiencies
  • Responses from the hospital blood bank should be received by the inspector 28 days after delivery of the post inspection letter.
  • The corrective action to be taken including the timescale will be reviewed
  • Further information may be requested and you may be required to provide evidence of satisfactory correction of the deficiency
  • Close-out letter sent when inspector assured that the deficiencies have been adequately addressed

These guidelines on 'The MHRA Hospital Blood Bank Inspection Process' are available for pdf (18KB) download.