A doctor writes: What went wrong at CervicalCheck in the Vicky Phelan case

Do its labs follow best practice, and why wasn’t a flag raised for three years?

Cancer screening: cervical smear specimens are stained and then examined under a microscope. Photograph: Mauro Fermariello/Science Photo Library/Getty

Cancer screening: cervical smear specimens are stained and then examined under a microscope. Photograph: Mauro Fermariello/Science Photo Library/Getty

 

The treatment of Vicky Phelan and at least 14 other women by CervicalCheck, the national cervical-cancer screening service, falls far short of accepted practice. Two issues must be addressed: is the standard for interpreting smears used by the three laboratories contracted to do so in line with international norms? And why did it take three years to tell these women that they were subjects of a look-back audit that found abnormalities in their smears, contradicting the results they had originally been given?

CervicalCheck has screened more than a million women between the ages of 25 and 60 in the 10 years since the free service began. It has reached its target of 80 per cent coverage. Unlike BreastCheck, which uses specialist mammography facilities to screen for breast cancer, it outsources the taking of smears to general practitioners and well-woman clinics. But, crucially, it invites women to be screened and has overall responsibility for the service.

Doctors have an ethical duty to keep their patients fully informed of test results, including of any doubt about the quality or accuracy of an investigation

Although the doctor who takes the smear is sent the result by the laboratory, and the woman gets a letter from CervicalCheck to say her result is available from her doctor or practice nurse, both the laboratory and the smear-taker act as subcontractors to the screening agency. As such CervicalCheck sets the standards and protocols that dictate how quality issues such as look-backs are dealt with. In other words, although the women’s doctors will be involved in the ongoing management of cases such as Ms Phelan’s, they have no role in decisions to withhold information.

It is absolutely unacceptable for doctors treating women who were wrongly given the all-clear from cancer to be told to exercise their “judgment” about whether to tell them about the misdiagnoses, as documents before the High Court in Vicky Phelan’s case show. In fact individual doctors have an ethical duty to keep their patients fully informed of test results, including of any doubt about the quality or accuracy of an investigation.

Sadly, this is not the first time in recent years that the health service has ignored patients’ rights to information about their health, and the need for candour has been acknowledged in previous instances of cancer misdiagnosis. So the time has come for the Republic to emulate the UK and introduce a duty of candour.

Yet again the public is indebted to a brave woman who pursued answers and refused to be fobbed off by a monolithic health service

Although the quality of laboratory services used to read smears must be part of a review, it is worth remembering that, even in the most accomplished hands, the process can never be totally accurate. As with all medical tests, cervical-cancer screening produces false-positive and false-negative results. The key question is one of quality: do laboratories used by CervicalCheck follow best practice, and are their false-positive and -negative rates within internationally accepted parameters?

Minister for Health Simon Harris must ensure there is a thorough, top-down external review of the screening agency. This must be carried out by the Health Information and Quality Authority, which has a strong record of impartially reviewing problem areas in the health service.

Yet again the public is indebted to a brave woman who pursued answers and refused to be fobbed off by a monolithic health service. It is a timely reminder that information about our health belongs, in the first instance, to each and everyone of us.

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