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

MHRA Requirements

Blood Safety and Quality Regulations 2005 (SI 2005 No 50) NHS Operational Impact Group (OIG)

Systems / documentation which MHRA advise Hospital Blood Banks need to formally confirm they have in place by 08 November 2005

Item

OIG QMS spec ref#

Descriptor

1 intro It is recommended that the outline quality management system specification prepared by OIG be incorporated within a Quality Manual which describes the quality system in the hospital blood bank.
 
2 1.3

There is an individual who has designated responsibility and authority to ensure the effective operation of the Quality Management System.
 

3 1.4

Staff are provided with timely, relevant and regularly updated training including an induction programme.
 

4 3.1

There is a controlled document system in which written procedures describe the work processes and which are regularly reviewed to keep them error free and up to date
 

5 3.2

Appropriate records are maintained within Health Boards / Health Authorities / Trusts. With regard to records which permit the traceability of blood from donor to patient (or final fate if not transfused) the following data items need to be available and accessible for 30 years:
 

  • Donation number
  • Component type
  • Blood establishment which provided the blood component
  • Date provided
  • Identity of patient who received the blood component or final fate if not transfused.
Health Boards / Health Authorities / Trusts shall determine how this requirement is met eg; by entry into a computer database at ward or in the blood bank or by making a record available which is stored separately from the patients notes, possibly in the blood bank, to facilitate storage for 30 years.
 
6 4.4

There is a formal, documented system in which management regularly reviews the performance of the Quality Management System.
 

7 4.5.13

There are standard operating procedures for the storage, distribution and transport of blood and blood components within and outwith the Hospital.
 

8 4.5.16

There are standard operating procedures covering temperature controlled storage, its monitoring and management of the "cold chain".
 

9 4.5.17

There are standard procedures for the validation and calibration of processes and equipment.
 

10 4.5.18

There are standard operating procedures for the notification of serious adverse events and reactions that satisfy the requirements of the Blood Safety and Quality Regulations 2005.
 

11 4.5.19

There are standard operating procedures that allow Blood Banks to accurately, efficiently and verifiably withdraw blood and blood components involved in serious adverse events or reactions or that are judged to have the potential to cause harm to patients.
 

12 5.1

Serious adverse events and serious adverse reactions must be notified to the competent authority, or an agency approved by the competent authority, in a timely and efficient manner
 

13 5.2

There are procedures that allow Blood Banks to accurately, efficiently and verifiably withdraw blood and blood components involved in serious adverse events or reactions or that are otherwise judged to have the potential to cause harm to patients.
 

 

Systems / documentation which MHRA advise Hospital Blood Banks need to formally provide a projection for their planned compliance

Item

OIG QMS spec ref#

Descriptor

1 4.3

There is a formal, documented system for change control.
 

2 6.1

There is an ongoing programme of self inspections (audit) which includes periodic audit of compliance with the "traceability" requirements of the Blood Safety and Quality Regulations 2005.