You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Blood banks get qualified all-clear from TGA

Related information

Media release

19 September 2003

The Therapeutic Goods Administration (TGA) has now audited all the major Australian Red Cross Blood Service (ARCBS) sites that undertake manual testing and manual entry of data and have found a general degree of adequate training, processes and procedures in place.

Last week the TGA placed restrictive conditions on the manufacturing licence held by the South Australian ARCBS, requiring them 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.

This follows an audit of the Adelaide blood bank during which the TGA found a number of breaches of the Good Manufacturing Practice Licence held by the Blood Bank. The most serious breach was the release of some blood products labelled as negative to cytomegolovirus (CMV) when in fact these were CMV positive.

The TGA is also investigating other breaches at the Adelaide blood bank including the release of a unit of blood before it was adequately tested for syphilis. Subsequent follow up by the ARCBS has shown that all of the blood released was in fact negative to the disease.

TGA audits undertaken last Friday and during this week of blood bank sites in Brisbane, Sydney, Melbourne, Perth and Darwin found that adequate training, processes and procedures are in place to protect public health and safety at these facilities.

However, auditors have expressed some concerns about training records for the manual entry of test data at the Alice Springs site. As a result, the Alice Springs ARCBS has agreed that all their manual entry of test data will cease, until they have had the opportunity to address these concerns following receipt of the written audit report.

The TGA is expecting to finalise all the written audit reports early next week.

Media contact: Kay McNiece, Media Adviser, TGA 02 6289 5027 or 0412 132 585