Several senior figures in the health service were aware of “concerns” with CervicalCheck’s approach to audits that uncovered incorrect smear test results in the middle of last year, correspondence shows.
The current controversy centres around cases where CervicalCheck, the national cervical cancer screening programme, did not inform women who developed cancer after audits found past smear tests incorrectly gave them the all-clear.
On June 20th, 2017, Limerick gynaecologist Kevin Hickey raised concerns with CervicalCheck's response to cases where incorrect smear test results were identified in a letter to Paul Burke, chief clinical director of University of Limerick Hospital Group.
In his letter, Dr Hickey said clinical director of CervicalCheck Dr Gráinne Flannelly felt just three women on a list who developed cervical cancer should be told about previous incorrect smear tests. However, Dr Hickey took the decision to inform all the affected women on the list.
“I have insisted that this be put on the agenda for discussion at the lead colposcopy meeting at the end of August, as I feel the process is not robust,” he told Mr Burke.
The private correspondence was submitted in the High Court case taken by Vicky Phelan, a 43-year-old Limerick mother of two with terminal cancer, who was not told about an incorrect 2011 smear test until September 2017 despite a 2014 audit by CervicalCheck showing that the test was wrong.
On July 10th, Mr Burke passed on the concerns to Dr Colm Henry, national clinical advisor and programme lead for acute hospitals.
Dr Flannelly responded to the concerns in a letter on August 4th, writing if “doubt exists” that a woman’s cervical cancer might have been detected in an earlier test, “or if she required more intensive treatment than she otherwise might have needed, it is our view that women should be made aware of this, rather than simply filing the report in the notes.”
Review
However, a review of 206 cases where women missed early treatment for cervical cancer is expected to find that in around half of cases women were not informed of the delay in their diagnosis.
Last week Dr Flannelly stood aside over the controversy, and the Government is to hold a statutory inquiry into the matter.
In her letter she also said: “It is important to stress that the review process differs significantly from primary screening - the reviewers are aware that a cancer has developed, and their focus is on identifying any cells which might have been interpreted differently.”
Later in August, Dr Henry sent the CervicalCheck chief’s response to Mr Burke, asking if it “addressed satisfactorily” the concerns raised.
University Limerick Hospital Group and the Health Service Executive have been asked for comment on what further steps, if any, Mr Burke or Dr Henry took in response to concerns over CervicalCheck's audit programme after August.