Efforts to get Department's approval for test outlined

IT took 18 months to introduce hepatitis C screening "for the safety of blood" after the test became available in 1989, the tribunal…

IT took 18 months to introduce hepatitis C screening "for the safety of blood" after the test became available in 1989, the tribunal was told yesterday.

Mr Ted Keyes, a former chief executive officer and accountant, said charging hospitals for blood and blood products was the BTSB's source of income - but it could not raise prices to fund the screening test without depart mental approval.

The board was an agent of the Department. The board's budget would be agreed with the Department and an allocation agreed.

"I was disappointed that it took so long. Once our board took the decision, they expected us as management to implement it," he said. Screening was finally introduced in October 1991.

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Dr Terry Walsh, then BTSB director, wrote to the Department of Health six times in the 18 month period before screening was introduced, requesting approval, the tribunal also heard.

Mr James Nugent SC, for the tribunal, said Dr Walsh had expressed extreme concern at the time, saying it was imperative the hepatitis C test was introduced.

Dr Walsh said his recollection was that most "transfusionists" recommended and saw the necessity of the test. "Our stated position all along was that we should introduce the test. We could not do so without the approval of the minister," he said.

Mr Nugent said a test, known as the ALT test, for the virus was first recommended by the BTSB to the Department four years before screening began in 1991.

Over a year before - on February 7th 1990 - the BTSB had expressed "extreme concern" that the test, which had a high accuracy rate, had not received departmental approval.

Haematologists in Dublin's Beaumont, Mater and St James's hospitals also put pressure on the Department to introduce the test - but the Department appeared to be looking to London for its lead, Mr Nugent said. Dr Alfie Walsh, the Department's chief medical officer, had been told that the test gave too many "false positives", where hepatitis C cases were mistakenly identified.

In May and November 1990 the Department was again contacted by the BTSB when Dr Walsh, its then director, urged that the test be introduced. Twice in February 1991 Dr Walsh requested departmental approval for the test.

Following a final plea in June, approval came in September and screening began the following month.

The new US test, with an 80 per cent accuracy rate for detecting the virus, was first recommended by the BTSB in September 1989, following concerns at the introduction of EU product liability legislation a year before.

"The Department seemed to take the view at that stage that if the test, which was only just being introduced at the time, lived up to what it said it could do, then the test should be introduced," Mr Nugent said.

For donors there was a real problem. "Here you have somebody who has proved that there is an 80 per cent chance that he or she may have hepatitis C. But short of a liver biopsy at that stage, there was not anything by way of confirmation," he said.