AQW 47507/11-15

Mrs Jo-Anne Dobson
Ulster Unionist Party
Upper Bann

Tabled Date: 22/06/2015
Answered On Date: 22/10/2015
Priority Written: No

Question:
To ask the Minister of Health, Social Services and Public Safety for an update on the Asceptic Unit Audit which was conducted by a Regional Quality Assurance team at Craigavon Area Hospital in December 2014; and to further detail any non-compliance issues were raised by this audit.

Revised Answer:

The RQA’s December 2014 Audit made 9 findings. Of these one was classed as ‘critical’, one as ‘major’, and 7 as ‘other minor’. The critical finding related to the facilities themselves which it judged did not meet EU requirements. A business case has been submitted to the Department and will be considered alongside other capital priorities. Other findings, related to aseptic processing; monitoring; documentation; product approval; materials, components & consumables and adherence to audit schedule, have been addressed. Work to address findings relating to personnel, training & competency assessment and the need for comprehensive contingency plans was completed in September 2015.