Pregnant women must be told of foetal anomaly test limitations

Pregnant women undergoing tests for possible foetal anomalies must be given more information about the tests’ shortcomings, the State’s maternity hospitals have been told.

The instruction from the HSE's head of women and infants health programme, Dr Peter McKenna, was prompted by the case of a woman who had a termination at the National Maternity Hospital last March after being given test results that proved incorrect.

The information provided to women taking prenatal tests must be “correct, full, individualised and documented”, Dr McKenna said in a letter to the heads of the 19 maternity hospitals.

In the light of the National Maternity Hospital case, it was “timely” to remind staff diagnosing pregnancy anomalies and carrying out terminations of the importance of providing “accurate” information about prenatal testing, particularly non-invasive prenatal testing.

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Patient profile

Dr McKenna said staff should note the positive predictive value of testing depends on “context and patient profile”. “This needs to be conveyed clearly to patient in a way that communicates the limited specificity (true negative rate) of this particular test.”

The value for high-risk women testing for Down syndrome, for example, shows a 20 per cent risk of an incorrect result.

In his letter, written in late May, he noted an independent review of the case was being carried out by the National Maternity Hospital. However, eight months after the woman had the termination, the promised independent review has yet to begin because of disagreements over the composition of the review panel.