BREACHES in the Blood Transfusion Service Board's (BTSB) own quarantine guidelines for blood plasma donations were discovered in an inspection carried out in 1992, the tribunal of inquiry was told yesterday.
The inspection by the National Drugs Advisory Board (NDAB) also found that the design of the anti-D manufacturing unit in Pelican House was inadequate and allowed for environmental contamination.
Mr John Lynch, a pharmacist who as a NDAB inspector had responsibility for inspections of the BTSB since May 1990, agreed with Mr John Rogers SC, counsel, for Positive Action and the McCole family, that a November 1992 inspection - the first in four years - revealed that their unit did not comply with good manufacturing practices, and that there was "a serious lapse" in observance of Council of Europe guidelines on the stipulated six-month storage period for plasma donations.
Up to then, there had not been a similar type of inspection at the BTSB because the issue of donor selection assumed greater importance in the mid to late 1980s with increasing knowledge of HIV and other viral transmissions. The NDAB became aware in October 1992 that Irish haemophiliacs had contracted hepatitis A, apparently through infected Factor 8 blood product.
He said the NDAB was concerned at the rumour and an intensive discussion followed. It was decided that an inspection of the BTSB's manufacturing facilities should be carried out, which would cover the preparation of plasma for export to Austria where it was manufactured into blood products for use by haemophiliacs on its return to Ireland.
He told counsel he had not requested to see books containing records of "adverse reaction" to donations, and said he was unaware if there was such a book. He had no knowledge that plasma from an exchange patient (Y) was used until October 1993. "It was a clear contravention of Council of Europe guidelines and would have been a reason to stop the manufacturing and withdraw the particular batches," he said.
The anti-D manufacturing depended on a pool of 14 donors whose plasma, according to the guidelines, should be stored for a six-month quarantine period. But he observed that in one pool of 10 donations, two had been stored for shorter terms.
"I actually raised it. Mr Hanratty (the Chief Technical Officer) said that the donors concerned had been back to donate since and had been retested. At the time I had no reason to doubt Mr Hanratty and at the time they had a tight pool of donors," he said. That was the only explanation he got for the breach.
"My concern, from the quality assurance point of view, was the assurance that the donations were free, insofar as it is possible, of viruses," he said.
In his report following the November 1992 inspection, he also criticised the manufacturing unit's pressurised air system, which allowed the possibility of contamination from bacteria, moulds and yeasts. But this would not include viral contaminants, he said.
He agreed with Mr James, Nugent SC, counsel for the tribunal, that Dr Terry Walsh, the chief medical consultant at the BTSB, had said they were considering transferring the anti-D manufacturing process to a firm in Canada, which operated to a higher standard.
Mr Lynch added that there had been "a chronic backlog of inspections" when he joined the NDAB in 1987 and extra EU regulations increased the board's workload.