While cervical cancer screening has been shown to save lives, the oft repeated mantra that ‘no test is 100%’ doesn’t quite convey the limitations of the testing.

A recently-released Department of Health brief stated that the screening is 60%-75% accurate.

How safe is a service that exports some of its smears to the United States for testing?

In 1987 the Wall Street Journal ran a series on ‘a Pap-screening industry kept afloat by overworked, under-supervised, poorly-paid technicians’. That series, depicting ‘Pap’ mills churning out cervical smear reports in huge numbers, often at the expense of quality, led to legislative change. CLIA (the Clinical Laboratory Improvement Amendments of 1988) limited the number of slides a technician could read for diagnostic purposes to 80 per day, plus another 40 for quality control. Each slide (one per case in the US) contains 50,000-200,000 cells. That legal limit was later raised to 100 (to cover all readings). Now, with the advent of computerised readings, even that cap is being exceeded.

The fact that cervical cancer screening carries an accepted false negative rate of 5%-10% underlines the need for high-quality testing. Guidelines for Quality Assurance in Cervical Screening is Ireland’s rule book for quality assurance. In the second edition, published in 2014, the National Cancer Screening Service states that all laboratories must be certified to ISO 15189 ‘or equivalent’ (p 50). Only one of the laboratories used by CervicalCheck, Medlab Pathology, shows evidence of this international standard for medical laboratories on its website, however.

The State guidelines seem to have been written with the outsourcing of smears to other jurisdictions in view. The NCSS is vague on key issues, including qualifications, saying only that laboratory staff should be qualified according to national criteria (p 53, 4.2.3).

A similar attitude is taken to the signing-off of laboratory reports, where, again, ‘national legal requirements’ rule. Reports may be signed off by technicians but abnormal results ‘will only be reported by a pathologist’. Such confidence may be misplaced. A class action taken against a University of Pittsburgh Medical Centre hospital in 2005 revealed that computer-generated smear reports bearing pathologists’ names were read only by technicians.

New research in the US shows that deaths from cervical cancer are significantly higher than previously thought. Several causes of death have emerged in the courts. Technicians are no longer viewing all cervical cells on a slide, as they used to. Instead, they examine those pre-selected by a computer. In major laboratories with an eye to the bottom line, staff now read north of 130-140 slides daily, up from a maximum of 80-90 when readings were all manual. Routine screening takes 4-5 minutes on average and often involves no more than one viewer. Set against this background, the limits laid down by the NCSS for quality control seem fanciful. Screeners, the NCSS says, should work a maximum of six hours daily over 24 hours and carry out no more than 12,000 primary screens yearly (p 58, Standards 4-10 to 4-11). (A primary screen is one done, apparently, for diagnostic purposes.) Observing this NCSS cap would mean each technician would do no more than, say, 50 of these screens in a day. It seems unlikely that large-for-profit laboratories in the US would cut back their productivity in this way for a client (CervicalCheck) 3,000 miles away.

With an eye to the US laboratory scene, perhaps, the NCSS envisages that all smears may be read by computers. The guidelines state that all samples should receive ‘a full manual primary screen’ unless the lab is ‘notified’ by CervicalCheck that ‘automated assisted screening’ is allowed. Another ‘quality requirement’ is that all samples (except those for reassessment) must receive ‘a manual rapid re-screen’, which ‘should take approximately 60-90 seconds’ (p 60). In the alternative, this re-screen may be done by a computer. In Ireland, in contrast, according to the Academy of Clinical Science and Laboratory Medicine, all smears are screened independently by two medical scientists trained as cytologists. This is in line with the highest international standards. Until the public laboratory services were dismantled by the State, medical scientists read just 25-30 cases daily. Overworked staff risk misreading slides.

Medical laboratory standards matter: women have had bilateral mastectomies in the US following wrong BRCA gene results. Yet the laboratory industry there is still unregulated, according to the Wall Street Journal. A 2015 headline on what it termed a ‘multi-billion dollar a year business’ asked: ‘is laboratory testing the “Wild West” of medicine?’ The focus of the article was on non-standardised tests, including for HPV and ovarian cancer, developed ‘in house’ and found by the Food and Drug Administration to be ‘problematic’. Ireland was the first country in the world to outsource all of its smear tests to overseas laboratories. Outsourcing began in 2006, when Quest Diagnostics, a large-for-profit laboratory in New Jersey, was given a ‘backlog’ created by State under-resourcing to clear.

Quest figures subsequently showed that its staff were finding one-third fewer pre-cancerous cells than Irish scientists in the same population. The fact that Quest’s diagnostic rate was 30% lower than that of Irish laboratories sparked widespread concern among medical scientists, pathologists and gynaecologists. This was ignored.

In 2008, the NCSS gave Quest a two-year contract to read Ireland’s 300,000 smears. It later declined to disclose the value of the contract, paid for by taxpayers, citing ‘commercial confidentiality’. Mary Harney, then health minister, subsequently revealed that Quest’s tender was one-third lower than the lowest Irish bid. Quest secured a further contract in May 2010, but this time the NCSS divided the cake, giving just 75% of it to the New Jersey company. Last year, Quest and a subsidiary, Berkeley Heartlab, paid $6m to resolve a US government lawsuit alleging that Heartlab had bribed doctors to order expensive but medically unnecessary blood tests. Quest continues to read Irish smears.

Sonic, which claims to be the third largest provider, globally, of pathology and clinical laboratory services, entered the Irish market in 2010, when the Australian corporation was awarded the remaining 25% of the two-year State contract. One of the terms of that contract was that Sonic would establish its own laboratory in Ireland. This raises many questions, not least the guarantees that may have been given by the State to make such a costly venture by a for-profit company worthwhile. Pending the opening of Sonic’s laboratory in Ireland, the testing was to be carried out in Austin, Texas, by CPL (Clinical Pathology Laboratories), a subsidiary. MedLab Pathology opened its doors in Sandyford, Dublin, in August 2010, and secured ISO 15189 certification 18 months later, in December 2011. In 2012, the State gave further contracts to MedLab (and Quest), again based on the cheapest price. The HSE recently confirmed that, during busy periods, MedLab outsources CervicalCheck smears to a brother corporation (the Doctors Laboratory, in London).

CPL, MedLab and the Doctors Laboratory are all owned by Sonic. Sonic is listed on the Australian Security Exchange: its 2017 report shows that revenue was up 7.9% to AUS$2.67bn. Total cash remuneration to June 30, 2017 for its CEO, Dr Colin Goldschmidt, came to more than $5m.

High Court records show that Dr Goldschmidt is a director of MedLab. That company is a defendant or a

co-defendant in five of the 10 legal cases being brought in Ireland arising out of incorrect smear test reports. Its brother laboratory, CPL, recently paid out €2.5m to Vicky Phelan in settlement of her case. Quest is a defendant or co-defendant in five other similar cases.

Successive governments, aided and abetted by the Department of Health and others, have long planned to privatise the nation’s laboratory service, and they have all but succeeded.

In 2007, Teamwork, under commission from the HSE, sounded the death knell for public laboratories and proposed several centralised, high-volume, standalone facilities, dividing laboratory services for patients from their hospital treatment. MedLab is the first. Cervical screening was performed in screening centres and diagnostic laboratories in Ireland for 40 years, until CervicalCheck began in 2008. In that year, the systematic dismantling of Ireland’s cytology laboratories began with the redeployment of 60 specialist scientists. One public laboratory survived the culling. Today, just one of the three laboratories currently used by the NCSS is a not-for-profit (the Coombe Hospital).

The State’s rule book has evidently been written with the needs of large, commercial, automated laboratories in mind, not patients. The standards drawn up by the NCSS for cervical smear testing fall far short of Irish laboratory standards. The oft-repeated claim, first made by the NCSS in 2010, that ‘each smear test sample analysed at each [US] laboratory will be double screened by two separate cytotechnologists’ now stands exposed as baseless.

Of the three laboratories currently used by CervicalCheck, two are facing legal actions by women whose cancers, tragically, were not picked up in time to prevent them from developing invasive disease.

In a country where smears are taken only at 3-5 yearly intervals, the only safe model of care is a not-for-profit one, where treating doctors may confer on site with laboratory staff, and test results accumulate in that hospital laboratory over time. If we wish to save women’s lives, cost cutting can no longer be allowed to drive the Government’s approach to cervical cancer screening.

Marie O’Connor is the author of Emergency: Irish Hospitals in Chaos