The North Western Health Board has promised to carry out a full investigation into a cervical cancer screening blunder which led to 68 women being incorrectly told that their tests were clear.
A review of checking procedures is also to be carried out after it took over a year for the board to detect that the results were inaccurate. These 68 women are only now being given the results they should have received a year ago.
About 13 of them have been advised to see a gynaecologist immediately, while the remainder, found to be borderline cases, have been told to have repeat tests done.
Doctors in the region yesterday reported receiving calls from many women who were worried about their own test results after hearing of the blunder.
At a press conference in Bundoran yesterday, the CEO of the NWHB, Mr Pat Harvey, said that the majority of the 68 women had been contacted and the remainder would be notified by their GPs within hours.
He said the board would co-operate fully with the Department of Health in any inquiry it might carry out, and it did not rule out taking legal action against the private Dublin laboratory which carried out the tests.
About 2,000 tests on women in the NWHB region between August and December 1997 were sent to the external laboratory, Claymon, after a 16-week backlog had developed at Sligo General Hospital. The women concerned were given the results between February and June last year.
Last January an audit found that significantly fewer abnormal smears than expected had been identified among the 2,000, and they were all sent to a laboratory in Glasgow for rechecking. It was then found that 68 tests had been inaccurately reported.
Dr Anne Kilgallen, a specialist registrar in public health with the NWHB, said it was important to emphasise that cervical smear tests were designed to detect changes in cells long before cancer developed. While the delay was unacceptable, it was unlikely to affect the final outcome for the women concerned.
"In up to 70 per cent of women, when the smear is re-tested the cells will have returned to normal. If this is not the case, and if changes are still present, treatment is straightforward and effective", she said.
The NWHB generally does all its own testing at Sligo General Hospital, and an external laboratory had been used only once previously, when a backlog had also developed.
It is recommended that screening take place within four weeks of the test being carried out to minimise the worry caused to women.
Mr Harvey admitted that staff numbers at the laboratory in the Sligo hospital had not increased since 1997. "We have not increased the resources in the Sligo General Hospital lab at this stage," he said. It was not a service which could be extended "overnight".
The director of public health at the NWHB, Dr Sean Denyer, said the 1997 backlog had developed due of a combination of factors. Numbers coming forward for screening had increased from 6,000 in 1992 to almost 9,000 at present.
"Problems come in relation to people taking leave, being on holidays, doing further qualifications, and sometimes there are weeks when slides build up", he said.
The NWHB said the fact that the errors had been uncovered proved that effective checks were in place.
Referring to the delay before the errors were detected, Dr Denyer said they would be "very concerned" to reduce this time period if a similar situation arose again. "We obviously will, when we cope with the immediate problem of identifying and speaking to the women concerned, have full reflection on any ways we can possibly improve the already rigorous checks we have in place."
He said that while daily quality-control checks were made on work carried out at the Sligo General Hospital laboratory, an audit of the scale of the one carried out in January only took place every three to six months. "When you receive assurances from a laboratory who are using personnel who would seem to have bona fides and credibility to do the work, you are obviously taking a certain amount on trust", Dr Denyer added.
It was pointed out at yesterday's press conference that there is no system in Ireland under which laboratories are approved for cervical screening.
Dr Denyer said that he wanted to reassure the 68 women that the time lapse was "not extreme". He added: "In terms of the length of time it takes for serious things to develop, it hasn't been an extraordinary length of time."
Mr Harvey said that when the work was contracted to the Dublin laboratory, which the NWHB did not name yesterday, the board had insisted on knowing the nature of the qualifications of the personnel there and had been reassured that the laboratory would be "exercising the same protocols that we have in Sligo".
It was confirmed that no NWHB representative had visited the Dublin laboratory, but Dr Denyer said there had been "lengthy conversations with them".
A national cervical screening programme is currently being piloted in the Mid Western Health Board area, and Dr Denyer said they were waiting for decisions to be taken on a number of issues, such as which laboratories were to be used for screening. "We can't really move on some of the issues until we know what their views are. We can't really invest in the lab when they might say, for example, that all screening is to be done in Galway," he said.
Mr Harvey did not rule out the possibility of legal action against the external laboratory. "I will have to satisfy myself in relation to all aspects of this case: the referral to the external lab, the standards that they applied, what procedures they followed, and we expect we will get full co-operation from that laboratory in that investigation. I will be pursuing it as appropriate then."
He said he had already put the board's concerns in writing to the Dublin laboratory.