MHRA Update - January 2009

Update from MHRA Blood Consultative Committee - January 2009

SABRE Update

MHRA + SHOT reports:  1521Increase of 40-45%

SHOT only:768Increase of 80%

Breakdown of reports:
SAR = 457
SAE = 1064

Reports submitted by Country:
England - 1260
Scotland - 87
Wales - 124
N. Ireland - 50

The annual summary reports are being dispatched and these need to be returned by the end of March

Current issues:

• No significant reported access or user problems
• SABRE accounts:

• Problems where email addresses are no longer active
• Messages ignored or the account is not regularly monitored

Numbers of Non Reporters:

Accessibility issues:

Work is ongoing with the standard to be achieved by 2010. It is hoped to implement these changes in Mar/April 2009. Some changes will be noticed by the users and the SABRE team will ensure the changes are communicated to the users at the appropriate time.

Recruitment of a haemovigilance specialist whose role will cover:

• Development of the "expert" panel
• Communications between SABRE and users
• Guidance and training
• Develop external relationships

Inspection update

Whistleblowers

There is a procedure in place across the Agency to protect the anonymity of the person providing information. The information will be reviewed to ensure:

• The information is genuine ( ie not supplied by a disaffected employee)
• Intelligence gathering from various sources

Provision of false and misleading information

The provision of false and misleading information on the compliance form may lead to a Cease and Desist notice being served on a Blood Bank. In the BCR supplied in April 2008 it has been identified on 3 separate occasions that the information provided did not sufficiently reflect what was happening on site. All such occurrence will be reported to the Inspection Action Group (IAG) and one site has been issued a "cease and desist" notice.

There have been 6 referrals to IAG following "for cause" inspections

In November the inspectors carried out their first unannounced hospital blood bank inspection and this resulted in an immediate "cease and desist" notice.

6/9 verification inspections have been completed

The 2009 Blood compliance report is unlikely to be significantly changed from 2008 form and should be available on the MHRA website by the end of February.

Update - Now avaialble at: www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2022577&RevisionSelectionMethod=Latest

Blood symposia

It has been identified that a number of sites are struggling with the concept or application of Good Practice. The programmes are structured to address areas where laboratories appear to have most difficulty. Presentations will be brief and there will be time for discussion of specific issues, and workshop sessions.

Importing blood from 3rd Country

Blood establishments who may import components from Third Countries need to assure that this is reflected on their Authorisation. Import of components for specific named patients cannot be used for another patient and hospital transfusion laboratories should be aware of this.

Blood fridges/Medical Devices

Blood fridges, freezers and platelet incubators are now classed as medical devices. Further information on the impact this may have will be available shortly.