Some doctors fear the outsourcing of smear tests will result in a lack of expertise and a low diagnostic rate, writes Theresa Judge.
DOCTORS WHO have claimed that cases of cervical cancer will be missed if the analysis of smear tests is outsourced to a private US company have been accused of making "a selective and distorted use of data" and of having a vested interest in the procurement process, by the chief executive of the National Cancer Screening Service.
"It is important that people understand that the people making these claims are those who find themselves at the wrong end of this procurement process," said Tony O'Brien.
The decision to award a contract to US company Quest Diagnostics to analyse all smear tests under the new National Cervical Screening Programme has become highly controversial.
It follows claims by consultant pathologists at some of the State's leading hospitals that up to 1,000 cases of cervical cancer a year could be missed if Quest does the analysis.
The decision has also been criticised on the basis that some 70 scientists working in public laboratories around the State will lose about half of their current workload, and that expertise and skills will be lost if practically all analysis of smear tests is carried out in the US.
It has also been pointed out that a course is now being run in the Dublin Institute of Technology (DIT) in cytology and so this decision will leave graduates with poor job prospects in Ireland.
Although the HSE has given a commitment that those scientists currently analysing smear tests in public labs will not lose their jobs, this raises the question as to whether alternative work will be found for them.
Quest's admission that it settled a number of multimillion dollar fraud cases with US federal authorities over the past 10 years over allegations of overcharging has also added to the controversy. These fraud cases were first highlighted by the advocacy group, Patients Together, last June and were known by the National Cancer Screening Service before Quest's tender was selected.
Tony O'Brien said he accepted it was "odd" that such a basic service as the analysis of smear tests in a national screening programme would be conducted outside of the State, leaving virtually no Irish staff with up-to-date expertise. "It is odd but it is a reality," he said.
Mr O'Brien said the objective of the National Cancer Screening Programme was "to get the service delivered and not to fix laboratories". His priority was the women who have been dying needlessly of cervical cancer - 90 in 2006 alone - and to provide them with accurate and fast screening. "A lot of this debate has been about fixing the public service, but let's put the focus back on the women who need the service," he said.
It was unacceptable that women in Ireland had been waiting for six months to get the results of smear tests, and a national screening programme could not be run on that basis, he said.
Mr O'Brien said he totally rejected very serious allegations made by pathologists at the Coombe Women's Hospital, St James's Hospital and St Luke's Hospital in Dublin, and University College Hospital, Galway that Quest's diagnostic rate - the detection rate of pre-cancer cells - was 30 per cent lower than that of Irish laboratories.
The pathologists said this figure was based on the results of analysis of Irish samples done by Quest in 2006 and 2007 when it was asked to clear a backlog of smear tests waiting for analysis. In their statement, the pathologists argued that, because some 3,000 Irish women develop pre-cancer of the cervix each year, 30 per cent or 1,000 women could be missed.
Mr O'Brien said the analyses done by Irish laboratories and by Quest were "not directly comparable" because all cases marked "urgent" were analysed in Irish labs and that this "skewed to a significant degree" the diagnostic rate. He said it was also the case that there were variations in pick-up rates even within the same lab from year to year.
A different method of analysis had also been used by Quest and the Irish labs, he said. When clearing the backlog Quest had reviewed every slide once and then 10 per cent of these were subject to "a random rapid review". Irish labs at the time were doing a full review of every slide and a "rapid review" of every single slide. Under the contract for the national screening programme, Quest would be doing a full review of every slide twice - by two different scientists - and therefore "more time will be spent reviewing each slide," Mr O'Brien said.
He said Quest had been selected as the preferred bidder because it had screened some 13 million smear tests last year, and is accredited by the American Association of Pathologists. It also guaranteed a turnaround time of 10 days for this analysis and it provided "good value for money".
While Mr O'Brien would not say how much cheaper than Irish labs Quest was "for commercial reasons", Minister for Health Mary Harney later said the Quest tender was at one-third of the cost of any from an Irish lab.
Mr O'Brien stressed that the issue of accreditation of labs was crucial. Irish laboratories, most of which are attached to large public hospitals, had been told in 2004 that only accredited labs would be used in the national screening programme, he said.
At present only three of the eight labs in the State are accredited and Mr O'Brien said he was "not willing to wait another two years" adding: "They were told this in 2004 - four years is long enough to wait."
However, Terry Casey of the Medical Laboratory Scientists Association said Irish labs could deliver a high quality service. He said the five labs without accreditation were due to be inspected later this year and he was confident they would then get accreditation. He accepted that the public labs would not have been able to meet the needs of the national screening service - a minimum of 300,000 tests a year - but said that "to send a message that none meet the criteria to deliver this important programme for the Irish public is damning".
Mr Casey blamed the Department of Health for not acting on the recommendations of the McCoogan report in 2004 to develop four specialist labs. He accused the Government and the department of "running down the existing service" by failing to provide important equipment. The result of this "dismantling" of the public laboratory service was that the cervical screening contract was now being awarded to a US firm and Ireland would lose vital expertise, Mr Casey said.
He called on Mary Harney to clarify what role she sees for the public cytology service in the future. Mr Casey said it would be very difficult for Irish labs to tender for the contract in two years because "the competency of staff will be compromised" by not doing the work for two years.
Mr O'Brien said that to say five Irish labs would be accredited later this year was like saying you had passed your driving test before you had done it.
The issue of the loss of expertise in this country was also raised very strongly by the Royal College of Physicians of Ireland's faculty of pathology, which is responsible for postgraduate education and training of pathologists.
A letter from the faculty's vice dean Dr Conor O'Keane to the National Cancer Screening Service before a bidder was chosen said outsourcing the screening would have "many negative consequences for patients and for future pathology training". He also questioned the methods of analysis used in the US.
However, this week after the preferred bidder was announced and after a meeting between the RCPI faculty and the National Cancer Screening Service (NCSS), the RCPI said in a statement that it had written to Mr O'Brien seeking "assurance on a number of items relating to the outsourcing of cytology services - in particular the effect this outsourcing may have on multidisciplinary team meetings, training and research".
The statement added: "Having met Mr Tony O'Brien, the NCSS have agreed to work with the faculty in what they describe as a collaborative working relationship in order to identify solutions to the issues which we have raised."
On the issue of multidisciplinary team meetings, Mr O'Brien insisted that it would be possible for doctors to talk to the person who analysed the smear test in the US through teleconferencing, and said this would be provided for in the contract.
On the issue of Quest's fraud settlements in the US, Mr O'Brien said that given that the federal authorities who had taken these actions against Quest "continue to recognise them as a valid provider" and to pay Quest for services, he did not see it as a reason not to use the company.