Plasma from Patient X main infection source

THE primary source for the infection of anti-D produced by the Blood Transfusion Service Board was through the taking of plasma from a woman, Patient X, in 1976 and 1977, and the use of that plasma to form pools from which the product was manufactured, the report found.

A further "significant" contribution to the infection of anti-D was subsequently made, arising out of the use of blood from a Donor Y, taken in late 1989 and used in anti-D batches issued between 1991 and 1994.

Patient X received a successful course of plasma exchange over 25 weeks while a patient in the Coombe Hospital in 1976/1977. The exchanges were carried out in Crumlin Hospital.

Her blood was used in the production of anti-D although she was not asked for her consent. The woman had a reaction to a transfusion on November 4th, 1976, and this fact was made known to the BTSB.

On November 17th, Patient X became jaundiced and was diagnosed as having hepatitis. The BTSB was notified. The BTSB applied to the Coombe to have a specimen of the patient's blood tested for hepatitis B. The test proved negative and the results of the test were signed by the National Director of the BTSB, Dr Jack O'Riordan. On the same date Dr O'Riordan sent a specimen to be tested for hepatitis B, to the Middlesex Hospital.

Between November 19th and December 8th, as part of her hospital treatment, samples of blood from Patient X were on 10 occasions sent to the BTSB for analyses to do with her treatment, and on each case an accompanying form, referring to her clinical condition, carried the words "infective hepatitis". The forms were signed by the then deputy national director of the BTSB, Dr James Wilkinson.

The tribunal report states that; by the middle of December 1976, "the entire senior medical staff concerned for the BTSB with this question of the plasma obtained from Patient X, that is to say Dr O'Riordan, Dr Wilkinson and Dr Terry Walsh, were all aware of a diagnosis of infective and the display of jaundice by the patient".

Notwithstanding this, further supplies of plasma were taken from the woman during January 1977 and included in plasma pools used for the production

16 batches of anti-D. The number of doses involved was probably over 5,000.

In July 1977, the BTSB was told by the Rotunda Hospital that three patients given anti-D in May 1977 had subsequently been diagnosed as having hepatitis. The doses came from the same batch, batch 238. It was suggested to the board, that the infections might be associated with the anti-D.

On July 25th, 1977, Mrs Cecily Cunningham, who was in charge of the laboratory where the anti-D was manufactured, was told not to use Patient X's plasma in any more donor pools.

The report notes that Mrs Cunningham told the tribunal she received no instructions as to what to do with the already manufactured batches or with those issued but not yet used. "She accordingly continued to issue the batches which had already been manufactured."

The targeted look-back programme subsequently discovered that the late Mrs Brigid McCole was treated with one of the 16 batches.