Two hospitals got same wrongly labelled blood

A UNIT of incorrectly labelled blood recalled from a maternity hospital was inadvertently sent to another hospital because of poor quality control at the Irish Blood Transfusion Service.

Documents released under a Freedom of Information (FOI) request reveal the blood in question was supplied to the Erinville Maternity Hospital in Cork with the incorrect hospital number, before being recalled and sent on in error to Cork University Hospital (CUH).

The Irish Medicines Board, who became aware of the error in an inspection of the Munster Regional Transfusion Centre (MRTC) of the IBTS, said: “The most serious impact could be that a unit that had been recalled could be re-routed to Cork University Hospital, thereby having the potential to cause harm.”

While units of blood were frequently re-routed from St Mary’s Orthopaedic Hospital, the Erinville, the South Infirmary/Victoria, and St Finbarr’s Hospital, to CUH, blood that is the subject of a recall is not.

A product is recalled when the IBTS is made aware that donated blood may have come from a donor with cold or flu or when a patient’s sample has the wrong hospital identification number, which means it would not be suitable for the patient for whom it was issued.

In the case of the unit which came to the attention of the IBTS, while it was not defective and, as such, posed no patient risk, it did highlight the IBTS potential to “inadvertently re-issue” blood which was the subject of a recall.

This, the IMB said, was in breach of standard operating procedure and led, last December, to the suspension of the IBTS re-routing programme. A spokesperson for the IBTS yesterday confirmed the programme remains suspended almost a year later.

On foot of the IBTS findings, Dr Joan Power, consultant haematologist and regional director of the Munster centre, requested an independent audit of the re-routing programme.

Carried out by GMP (Good Manufacturing Practice) Services, the audit recommended the IBTS end the practice of allowing re-routed units to be returned in the same delivery as units for discard, to avoid confusion.

As per the IBM report, GMP was critical of the checks carried out on the returned blood, with poor documentation and insufficient detail. The IMB also found “no evidence of assessment of transport times of red cell packs between the MRTC and its customers.”

Red cell packs should be received within two hours. GMP was critical of the use of a log book, rather than a computerised record, to check if a product is the subject of a recall or otherwise flagged as unsuitable for use.

The re-routing programme was suspended on December 9 last year by then acting chief executive of the IBTS, Andrew Kelly. However, a subsequent memo from Mr Kelly, now chief executive, to Dr Power reveals the strained relations between the Cork and Dublin IBTS branches, which led to the resignation of the former chief executive Martin Hynes, may still exist.

In his letter, Mr Kelly said: “Notwithstanding the fact that I had clearly suspended the re-routing programme, you (Dr Power) sent an email to heads of department at the MRTC, stating interalia: ‘The acting CEO has requested this morning that we do not run the re-routing programme this week until we have put appropriate corrective actions in place - expected by end of week.’ This email did not accurately represent the decision regarding the re-routing programme set out in my letter, dated December 9, 2003.”