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

2010 March

Update from MHRA Blood Consultative Committee - March 2010

SABRE Update
There have been more "team" registrations this year.

Reports as of March 2010:

MHRA + SHOT reports: 5604

SAR: 1678

SHOT only: 3195

SAE: 3926

 

England

N Ireland

Scotland

Wales

Number of reports

4514

191

378

521

 

There have been 18 deaths in this period with the following information regarding their imputability

Imputability < 1= 13
Imputability > 2= 5
Attributable= 3 ( 1 x rbc's, 1 x FFP, 1 x Platelet and rbc's)

773 cases have been excluded and these were for:

  • Clinical incidents
  • Anti-D/other medicinal products
  • Reporter decides the event/reaction is not serious
  • Duplicate entries

Currently there are 141 reports that are outstanding ie not confirmed (some of these will be TRALI cases which often take many weeks to confirm)

Non reporters = 26 and these are small/independent hospitals and some of these have never reported since the inception of the BSQR

It is intended to update the guidance and run some seminars once the EU definitions are confirmed, hopefully after June this year.

Regulatory information
It will not be possible for the MHRA to inform the supplying blood centre if a hospital is issued with a notice to "cease and desist". The MHRA advised that the technical agreement between the blood centre and the hospital should clearly state the responsibility is on the hospital to inform the blood service of a "cease and desist" notice, and vice versa.

Blood Compliance Report 2010
The BCR is now available on the MHRA website. There are also guidance notes and these should be read before printing or completing the form. The questions are broadly similar but the format is different ie not in word but Excel. The BCR must be completed and returned electronically by the 30th April 2010. The declaration can be scanned or returned as hard copy. Please ensure that the entries you have made when selecting Yes or No are correct.

There is a specific form for facilities (in word format) and this is to be completed by the facility where the supplying hospitals does not take the total control and responsibility for SABRE reporting, traceability and cold chain requirements.

This year there may be a change in the programme of control inspections. Previously there were 4 types of letters:
- compliant
- conditional compliance
- non compliant and notice of "for cause" inspection
- control site inspections

This year the control sites may not be specifically notified but the letters will indicate to the 'compliant' and 'conditionally compliant' sites that they may be chosen for a control visit within the year. The reasons for this are that the information provided on the BCR does not always match what is found.

Notifications for inspections will normally give a minimum of 2 weeks notice but this is not guaranteed.

Inspections - Hot Topics - (Slide show attached "Blood Bank Inspections - Common Deficiencies)

Specific points made:

  • Increase in concerns regarding the potential for "false and misleading information"
  • Action plans submitted following inspections were not completed in the timeframe indicated, without update to the responsible inspector
  • Concerns where incident reporting is not controlled and managed through the transfusion laboratory
  • SABRE reports not always timely
  • Training for out of hours staff does not always include QMS training

If you recognise that you will be unable to meet the timeframe submitted in your action plan, following inspection, you MUST discuss this with your inspector and agree a new timeframe

If you have indicated on the BCR some actions, then unable to complete these, this can be fed back through the generic email gmpinspectorate@mhra.gsi.gov.uk. The MHRA will ensure this is regularly visited and will, in future, respond to these.

Paper regarding Quality Control standards for monitoring Fresh Frozen Plasma (FFP)
This paper was presented by Graham Rowe, Welsh Blood Service, at the request of the MHRA inspectorate. The Regulations, under part 5 for "Plasma, fresh-frozen" requires Factor VIIIc to meet the following "acceptable results." "Average (after freezing & thawing): 70% or more of the value of the freshly collected plasma unit". This is an issue for all UK Blood Services. It was agreed that a paper from the UK, prepared by SACBC - Chair Chris Prowse, should be prepared and Ian Rees will take this to the meeting of the Competent Authorities on blood and blood components.

Regulatory Updates

  1. There is a Memorandum of Understanding between the HTA and MHRA in relation to sharing information where inspection by either identifies non compliances as the likelihood there may be organisational wide problems.
  2. Influenza - the time limited directive (relaxation of the deferral period) is in effect until June 2010 when it will cease
  3. Work ongoing as to whether there is a need to revise the current Hb level for donors
  4. Also consideration of the pH effect on platelets
  5. The Good Practice Guidelines will take into account the detailed principles and guidelines of GMP
  6. EUBIS - the manuals and training documents are ready and there will be a training session at the ISBT academy on the 27th June 2010. Validation courses will also be run in Prague and Budapest

Electronic Issue Guidance
Consultation is complete and the new guidance has taken into account issues raised. This will be available shortly on the MHRA website. Some concern was raised regarding the statement... that reagents and test systems are CE marked for their intended purpose, and are used fully in accordance with manufacturer's instructions. As the MHRA can not make information available relating to specific manufacturers it was agreed that OIG should prepare this information

Training and competency for persons collecting blood from the fridge
The factors for consideration should be:

  • Annual training and competency unless otherwise justified. The competency assessment can be questions or observation
  • GMP awareness should be included
  • How often staff collect
  • What to do after an extended period of leave
  • Are there systems in place which mitigate annual training needs? There may be justification for extending the timeframe to 18 months eg electronic systems where persons not collecting in the last 3 months can be removed from the system
  • Training could be by elearning and this may be more relevant for retraining
  • The training could be identified as annual +/- xx months but this would not be considered appropriate if training is 2 yearly +/- xx months. The maximum period between training should be 24 months.

MHRA workshops
There will be some more workshops during this year. These in essence will be repeats of those undertaken last year

Joan Jones
March 2010