Board had no protocol for virus testing

It was business as usual at the Lindsay tribunal yesterday after a seven-week break, with the spotlight staying on the role of…

It was business as usual at the Lindsay tribunal yesterday after a seven-week break, with the spotlight staying on the role of the Blood Transfusion Service Board and its former employees in the supply of infected blood products to haemophiliacs.

Despite the familiar theme, however, a fresh face was in the box - that of Mr John Keating, a former acting chief technical officer with the board and current employee of the Irish Blood Transfusion Service.

A specialist in microbiology and virology, Mr Keating was charged in the early 1970s with helping to develop hepatitis B testing in Pelican House. Thereafter, he played a central role in monitoring new testing methods for emerging viruses such as HIV and hepatitis C.

To what extent his evidence will be of significance remains to be seen. Little of what he had to say yesterday shed new light on the workings of the board, already portrayed in some detail by former employees in a less than favourable light. Yet some interesting points did emerge, most notably relating to the board's handling of the HIV crisis as it unfolded in the mid-1980s.

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One surprising disclosure was that the board failed to prepare a protocol on testing for the virus despite serious concern at the time about the possibility of HIV transmission through blood products sourced from both Irish and overseas donations.

Mr Keating confirmed that in July 1973 he drafted a very detailed protocol or "technical memorandum" on hepatitis B testing which was circulated to relevant personnel in the board. In October 1985, however, when HIV testing was introduced, a similar protocol setting out how products should be tested and what should happen to untested product was never prepared.

Mr Keating admitted he would have expected a protocol to have been drawn up. He could recall discussing the issue, presumably, he said, with Mr John Cann, the then chief technical officer, and while nothing came of the discussion, he said he did not believe there was a conscious decision not to prepare a protocol.

As an explanation, he said the technical section was "a small unit" and "we knew what we had to do but we did not necessarily write it all down".

The issue is pertinent as, arguably, if the BTSB had prepared a protocol on HIV testing it would have led to a more co-ordinated approach in the screening and recall of potentially infectious products and possibly helped to avoid infections.

If a protocol had been in existence, it might help explain why the board in November 1985 decided to carry out retrospective batch testing on Factor 9 clotting agent distributed to hospitals rather than recalling the product. The clotting agent in question was made from untested plasma donations and as a result, as Mr Keating said yesterday, it was potentially infectious.

Asked by counsel for the Irish Haemophilia Society, Mr John Trainor SC, if he knew who had ordered the batch testing, whereby samples of batches issued to hospitals were screened for HIV at Pelican House, Mr Keating replied he did not, but he was sure he had not initiated the instruction.

Furthermore, he rejected the claim by Mr Trainor that the batch-testing initiative was a means of assessing the BTSB's "exposure to liability". Mr Keating said the initiative was considered good policy by the board from a safety point of view and it was not concerned with liability issues.

Mr Keating's role within the board on viral testing and his possible input in the selection of products will be further examined under cross-examination.

Yesterday, he stated that product selection was the responsibility of his seniors: chief executive officer Mr Ted Keyes; chief medical officer Dr Terry Walsh; and to some extent senior technical officer Mr Sean Hanratty. However, he said he did provide advice to them and the board, on whose behalf he attended international scientific meetings dealing with HIV and hepatitis C.

Significantly, Mr Keating advised the board in July 1986 on a recommended method of heat-treating Factor 9. The standard of 60C degrees for 72 hours, which he endorsed in the light of information gained at a Paris conference, was subsequently adopted by the board.

Mr Keating is expected to be further quizzed on how he came to give this advice today, given, according to Mr Trainor, that no other blood bank or pharmaceutical company had been using the same method for Factor 9.