An inspection has found major deficiencies in quality assurance procedures at the headquarters of the Irish Blood Transfusion Service (IBTS).
The resulting report by the Irish Medicines Board (IMB) is critical of the speed with which incident reports and complaints about blood products are dealt with, as well as the documentation in relation to investigations.
The report was obtained under freedom of information legislation.
IMB inspectors found that in general a well-developed quality management system was in place at the National Blood Centre on St James’s Street in Dublin. Compliance with relevant blood legislation and good practices was demonstrated.
“While certain investigation reports were considered to be satisfactory, a deficiency was cited in that some incident reports were not progressed through the various stages of investigation and review, or closed, within an appropriate time frame.”
The issue was classified as a major deficiency, defined as a non-critical failure which could result in blood products that do not comply with the requirements of legislation.
The report says the investigation of product complaints was also deficient in that review notes were recorded on yellow sticky notes and supporting documentation was not available at all times.
Quality assurance did not have an overview or, in some cases, an awareness of investigations being performed in different departments relating to product complaints. The decision process about including a complaint on the suspected serious adverse event log was not clear.
Blood collection policy
The inspection is also critical of some aspects of the IBTS's blood-collection policy, in particular the collection of blood from people with low haemoglobin levels.
It says the policy of collecting blood from people with a haemoglobin level of 12-12.4 g/dl (males) or 13-14 g/dl (females) is below that specified in national and European legislation.
The management of donors with multiple deferrals for low haemoglobin “was not considered robust”, according to the inspection report.
As a result, the IBTS stopped bleed donors in borderline ranges for a time.
Specific deficiencies were also cited in respect to the management of three specific donors under review.
The report also notes an incident report after 2010 donation labels were used on 2011 components.
Complaints
A number of complaints were received from hospitals over discrepancies between the numbers used on packs and on despatch documentation.
“In general, the management of this issue was deemed adequate and the organisation was able to demonstrate that traceability of units had not been compromised.”
In a response, the IBTS accepted there was delay in closing out file paperwork in quality assurance, but insisted that all appropriate corrective actions were taken immediately. Stock shortages and communication breakdown were identified as major factors in some of the problems.
A senior post in quality assurance, which was vacant due to long-term sick leave, was to be replaced as soon as possible.
It undertook to introduce an information leaflet for donors who are deferred for a low haemoglobin count.
