CervicalCheck has not inspected test labs for four years

‘Opportunities were missed to develop the assurance process’

CERVICALCHECK has not carried out any of its own inspections of the laboratories doing cervical screening for four years. No quality assurance site visits to any laboratory in the United States or Ireland has been carried out since 2014. The revelation is contained in the report of Dr Gabriel Scally, who visited the labs as part of his investigation of the CervicalCheck scandal. Although he says that, from his evidence, there is no reason not to continue to use the labs, he is critical of the level of monitoring of the services by CervicalCheck. He said it is surprising the quality assurance inspections of the labs have not been conducted for such a length of time. “This is surprising and not in line with best international practice, which would suggest visits every three years unless there was a reason to actively change the schedule,” he said. “Any decisions moving quality assurance visit schedules either forwards or back should be discussed and minuted at a high level within the organisation.” He found that the early rounds of quality assurance checks of the labs done by CervicalCheck were limited in their governance, design and effectiveness. “Opportunities were missed to develop the quality assurance process and the absence of a further visit to all sites by 2017 has resulted in a failure to assure aspects of the quality of provision,” he warned. CervicalCheck is now expected to carry out inspection visits of the labs in the coming weeks. A separate investigation is also to begin into the decision of the CPL lab in Austin, Texas, which was used by CervicalCheck up to 2013, to outsource tests from Ireland to Honolulu and Las Vegas. Meanwhile, it has emerged that the number of complaints to the Medical Council from patients about alleged poor communication by doctors has remained consistently the number one grievance over many years. It follows the distressing accounts of women and families affected by the CervicalCheck controversy about the insensitive attitude of some doctors when they were given the delayed copies of audits showing they had received the wrong smear test result. There were 151 such complaints in 2015, and 136 in 2016. Last year the doctors’ watchdog received 126 of the allegations against doctors. Most never go to a full inquiry and efforts are made to resolve the issue, with doctors in several cases making an apology. Not all the complaints are upheld and in some cases the patient may notify the Council due to other issues which are outside the control of the doctor. In the case of the CervicalCheck audit reports, it has already emerged that several doctors felt it was not their task to tell the women and relatives about the results. They believed it should be CervicalCheck which should contact the people involved and provide a oneto-one meeting explaining the background. CervicalCheck had several of the audit reports on its files for at least two years before it sent them to the doctors in 2016 saying to pass them on to patients. In cases where a patient was deceased it was suggested the woman’s treating doctor merely record it on her file.