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

2007 July

Operational Impact Group – Update Report

The following information was supplied to the MHRA Blood Consultative Committee (BCC)

SABRE Update

As of 30th June 2007:

MHRA − 1449

SAE − 1013

SAR − 436

SHOT only − 965

Many Hospital Transfusion Laboratories have found difficulty in providing the figures required by the annual SABRE report of “units issued” which is a different requirement to the compliance form request of “units issued”. Ongoing work via the adverse event sub group will hopefully be able to clarify exactly what is required by the EU and this will be a figure that HTLs can easily provide.

Compliance Reports

There has been significant time spent by the Inspectors in “chasing up” sites who had not sent in a compliance form by the end of April 2007. Hospitals are reminded that it is a legal requirement for hospital blood banks to complete and return the compliance form. . Forms have been available on the MHRA website for some time.

Pre determined trigger factors were agreed, based on the risks to public health. Each form was assessed and in some cases further information was sought from the hospitals.

Triggers:

  • Unauthorised activity
  • Significant laboratory changes, or relocation
  • Purchase of new automated systems
  • No external accreditation
  • No system for reporting SAE/SAR
  • Traceability
  • Incomplete QMS

If hospitals recognised their “non compliance” and had an adequately resourced, robust system in place then they may have not been identified for inspection this year. Similar key themes and areas of non compliance were noted this year – quality system failings, incident reporting and CAPA, validation and change control (especially of automated and IT systems), maintenance and calibration and traceability issues.

From the initial 390 forms submitted, 191 were referred to the blood inspectors for further assessment. Following this 65 were marked for inspection , 2 were identified as “high risk” and for immediate visit. Sites which were referred for further assessment, but not included in the final inspection list, will be examined for evidence of improvement next year.

Letters have not all been sent out at the same time but it is hoped these will be completed by the end of July.

It is important that hospitals have a robust self inspection calendar that allows them to identify areas on non compliance with GMP critical areas.

Regulatory Authority for Tissues & Embryos (RATE)

  • May 2007 draft bill to establish RATE
  • Undergoing pre legislative scrutiny and consultation now
  • A report will be issued in Aug 2007 with possible revision of the Bill
  • Appointment of a shadow Chair and CE for RATE (2nd quarter 2008)
  • Shadow authority established
  • Formal consultation process

No details on how it will affect MHRA and its involvement with blood regulation is known

Good Practice Guidance

  • EU Commission obliged to develop Good Practice guidance for Blood and Tissues
  • Organisations asked to tender for both BE and Tissue establishments
  • May 2007 was the closing date
  • Review of the tenders began in June 2007
  • The contact is due for award in Oct 2007.
  • MHRA did not submit a tender, due to the current structure of the UK Regulatory framework for Blood and Tissues, which fall under the scope of separate UK Competent Authorities. MHRA will provide comment on the draft guidelines when provided by the EU Commission for review.

It is known they will refer to GMP

A website which may be useful is PIC/S GMP Guide for Blood Establishments

MHRA Compliance Report submission by Blood Establishments (i.e. where a BE performs aspects of Blood Bank activity)

  • Bi-annual inspection
  • More in depth
  • A risk assessment approach is taken for inspection/validation depending on what type of activity the blood bank is performing
  • Site master file detailing the activities on site should be available prior to inspection

Inspection data

MHRA have been asked to supply data from inspections in relation to the number of critical/major non compliances per site. Hospitals want to have a feel for how they are doing compared to other hospitals and would value this Information from the inspectors/inspections. It is hoped to be able to provide this data from last years inspections at the next BCC.

Attachment of compatibility labels

Following some inspections last year MHRA advised that compatibility labels should not be stuck onto bags unless :

  1. They can demonstrate that the glue has been validated not to "leech"
  2. Must not obscure the Blood Service labels.
  3. Must not interfere with any special function of the bag (e.g. gaseous exchange through platelet bags)

This advice has not changed and the many hospitals have got round this by using a "bag and tag" system. It would appear that the majority of HTLs in Scotland and Wales have moved to this system.