Operational Impact Group – Update Report
The following information was supplied to the MHRA Blood Consultative Committee (BCC)
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.
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.
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)
No details on how it will affect MHRA and its involvement with blood regulation is known
Good Practice Guidance
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)
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 :
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.