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Blood regulator takes action on South Australian Blood Service
The Australian medicines watchdog, the Therapeutic Goods Administration (TGA), which also regulates blood and tissues, today confirmed that it had placed restrictive conditions on the manufacturing licence held by the South Australian Australian Red Cross Blood Service (ARCBS).
Investigating the recall of blood by the Adelaide Blood Bank, the TGA conducted an unscheduled audit on 5th September 2003 of the Adelaide blood bank's facilities where the ARCBS collects, tests, processes and distributes fresh blood for blood transfusions. The audit found a number of breaches of the Good Manufacturing Practice Licence held by the Blood Bank.
The most serious breach was the release and use of 21 blood products labelled as negative to cytomegalovirus (CMV) when in fact these were CMV positive. These units had been tested, found to be positive, and then been incorrectly entered onto the National Blood Management system as CMV negative.
The audit identified a complete breakdown in the requirements of staff to follow standard operating procedures for CMV testing and data entry and would appear to indicate a failure in the control of testing and supervision with the testing laboratory involved. This practice is believed to have been in place for up to three months.
The TGA has been assured by the ARCBS that all of the wrongly labelled blood has been accounted for.
The conditions placed on the licence of the South Australian ARCBS by the TGA requires the ARCBS to use only fully automated tests for blood donor screening. These tests must be interfaced with the National Blood Management System and not require human interpretation or manual entry.
Cytomegalovirus, or CMV, is a member of the herpes group of viruses. Initial CMV infection, which may have few symptoms, is not usually a problem for healthy people, although people with a depressed immune system could become very ill.
In Australia a select number of blood donations are screened for CMV status in order to maintain a small inventory of CMV negative blood.
Media contact: Kay McNiece, Media Adviser, TGA 0412 132 585